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ATRIAL FIBRILLATION

Frequenty Asked Questions

FAQs

The FARAPULSE PFA System is currently approved with the intended use of isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent Atrial Fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arrhythmia initiation or maintenance.1

1. FARAWAVE/FARAWAVE NAV IFU

Yes. The FARAPULSE PFA System is currently approved with the intended use of isolation of the pulmonary veins in the treatment of paroxysmal Atrial Fibrillation by rendering targeted cardiac tissue electrically non-conductive to prevent cardiac arrhythmia initiation or maintenance.1

1.    FARAWAVE/FARAWAVE NAV IFU

Yes. The FARAPULSE PFA System has recently been approved with the intended use of isolation of pulmonary veins and posterior wall in the treatment of persistent Atrial Fibrillation.1 This approval comes after the publication of positive trial results, 2 including 12-month primary endpoint results from the ADVANTAGE AF clinical trial evaluating the use of the FARAPULSE Pulsed Field Ablation (PFA) System and adjunctive use of the FARAPOINTTM PFA Catheter, a focal pulsed field ablation catheter*, in patients with persistent AF. The second phase of the ADVANTAGE AF trial studied the FARAWAVE PFA Catheter for both pulmonary vein isolation (PVI) and posterior wall ablation (PWA) and the FARAPOINT PFA Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter (AFL), another type of heart rhythm disorder.*3

* Focal FARAPOINT Pulsed Field Ablation Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter, which is not currently commercially available.

1.    FARAWAVE/FARAWAVE NAV IFU
2.    FARAPULSE Clinical Compendium.
3.    Reddy VY, Gerstenfield EP, Schmidt B, et al. Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2. Circulation. Published online April 2025. Doi:10.1161/CIRCULATIONAHA.125.074485

The FARAPULSE PFA System was specifically engineered to deliver proprietary PFA therapy for optimised efficacy, efficiency and safety. One explicit goal was to overcome some of the safety concerns with traditional thermal ablation methods, particularly in terms of risk of damage to adjacent structures, such as the oesophagus and phrenic nerve.

  • In MANIFEST-17K, the largest pulsed-field ablation safety registry study conducted to date, including over 17,000 patients, there were zero thermal complications across all procedures with FARAPULSE PFA.1
  • Overall, low major adverse event rates have been reported in clinical studies. In the ADVENT US IDE randomised controlled trial (RCT), FARAPULSE PFA demonstrated non inferiority to thermal ablation in terms of safety outcomes.2

For more information, visit the Evidence Section of this website

1.    Ekanem E, Neuzil, P, Reichlin T, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). doi:10.1038/s41591-024-03114-3.
2.    Reddy VY, Gerstenfeld EP, Natale A, et al, ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.

The FARAPULSE PFA System was specifically engineered to deliver proprietary PFA therapy for optimised efficacy, efficiency and safety. In terms of effectiveness, evidence of additional benefits versus thermal ablation methods has emerged, including:

  • High freedom from arrhythmia recurrence and low rates of repeat ablation.1-3
  • Proven non-inferior efficacy compared to thermal ablation techniques.1 One RCT has shown superiority in freedom from atrial tachyarrhythmias at 12 months compared to cryoballoon ablation.4
  • Minimal atrial arrhythmia (AA) burden post ablation.4,5,7
  • Significantly reduced AA burden compared to thermal ablation, with an AA burden <0.1% increasingly recognised as being associated with a greater quality of life improvement.5
  • Minimal pain and faster recovery times for the patient.6

For more information, visit the Evidence Section of this website

1.    Reddy VY, Gerstenfeld EP, Natale A, et al, ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.
2.    Ekanem E, Neuzil P, Reichlin T, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). doi: 10.1038/s41591-024-03114-3
3.    Schmidt B, Bordignon S, Neven K, et al. European Real-World Outcomes with Pulsed Field Ablation in Patients with Symptomatic Atrial Fibrillation - Lessons from the Multicenter EU-PORIA Registry. Europace 2023;25(7):euad185. doi: 10.1093/europace/euad185
4.    Reichlin T, Kueffer T, Badertscher P, et al. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025;392:1497-1507. doi: 10.1056/ NEJMoa2502280
5.    Reddy V, Mansour M, Calkins H, et al. Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. 2024 Jul 2;84(1):61-74. https://doi.org/10.1016/j.jacc.2024.05.001
6.    Füting A, Neven K, Howel D, et al. Patient discomfort following pulsed field ablation for paroxysmal atrial fibrillation – an assessment of chest and groin pain using the Numeric Rating Scale. Clin Res Cardiol (2021)10.1007/s00392-021-01933-9
7.    Reddy VY, Gerstenfield EP, Schmidt B, et al. Pulsed Field Ablation of Persistent Atrial Fibrillation with Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2. Circulation. Published online April 2025. Doi:10.1161/CIRCULATIONAHA.125.074485

  • The ADVENT RCT demonstrated that the pulmonary vein isolation (PVI) procedure performed with the FARAPULSE PFA System requires 42% less time than thermal ablation technologies (radiofrequency ablation or cryoballoon ablation), reducing dwell time in the left atrium.1
  • Another RCT confirmed a FARAPULSE procedure time of under one hour, i.e. 18 minutes shorter than a cryoballoon ablation, and 25% faster.2
  • One RCT has shown that FARAPULSE PFA offers a significantly reduced atrial arrhythmia (AA) burden vs. thermal technologies. Residual AA burden is gaining acceptance as a more comprehensive measure of ablation efficacy, linking to patients’ quality of life and lower health care utilisation if below a certain threshold.3,4

For more information, visit the Evidence Section of this website

1.    Reddy VY, Gerstenfeld EP, Natale A, et al, ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.
2.     Reichlin T, Kueffer T, Badertscher P, et al. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025;392:1497-1507. doi: 10.1056/ NEJMoa2502280
3.    Reddy V, Mansour M, Calkins H, et al. Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. 2024 Jul 2;84(1):61-74. https://doi.org/10.1016/j.jacc.2024.05.001
4.    Reddy VY, Gerstenfield EP, Schmidt B, et al. Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AFPhase 2. Circulation. Published online April 2025. Doi:10.1161/CIRCULATIONAHA.125.074485

Since the introduction of the FARAPULSE PFA System pioneering the PF ablation field, and publication of positive clinical trial results, other PFA systems have emerged onto the market. It is important to note that PFA systems depend on a considerable number of parameters to ensure an optimal system design. From the design of the catheter used to deliver the pulsed field energy to the way the energy is delivered (waveform, number of applications, etc), every parameter plays an important role. Small differences in these parameters can have an important impact on safety, efficacy and efficiency, making it very hard to compare different PFA technologies.

The optimised combination of these parameters for the FARAPULSE PFA System has been extensively studied in pre-clinical and validated clinical studies. The FARAPULSE PFA System was designed from the ground-up for optimised PFA treatment, whereas some other systems use catheter designs that have been repurposed from other energy forms.

The wealth of evidence (>150 publications including 55 clinical trials) that now supports PFA has been generated with the FARAPULSE PFA System.1 No other system is supported by such robust evidence, and other PFA systems need to prove their safety, efficacy and efficiency over time, in their respective clinical programmes. The FARAPULSE PFA System is the most used PFA system in the world with 500,000 patients treated to date.2

1.    FARAPULSE Clinical compendium.
2.    Boston Scientific data on file.

Yes

  • Due to the non-thermal nature of PFA, cell death pathways that are activated after PFA are different from those activated after radiofrequency ablation, for example. This leads to a lower acute inflammatory response and a faster tissue healing process.1
  • Compared to thermal ablation, many patients report minimal pain and fast recovery times when treated with the FARAPULSE PFA System.2

1.    Osmancik P, Bacova B, Hozman M, et al. Myocardial damage, inflammation, coagulation, and platelet activity during catheter ablation using radiofrequency and pulsed-field energy. J Am Coll Cardiol EP. 2024;10(3):463–474.
2.    Füting A, Neven K, Howel D, et al. Patient discomfort following pulsed field ablation for paroxysmal atrial fibrillation – an assessment of chest and groin pain using the Numeric Rating Scale. Clin Res Cardio (2021); doi:10.1007/s00392-021-01933-9.

Following a comprehensive evidence-based review, NICE guidance now recommends PFA as a treatment option for Atrial Fibrillation.1 View the guidance here.

The FARAPULSE PFA System is backed by over ten years of research and over 150 publications, including 55 clinical trials.2 It has been commercially available for over three years and is the most widely used PFA system, with 500,000 patients treated around the world to date.3 For more information on the wealth of evidence supporting the technology, please visit the Evidence Section of this website

1.    NICE guidance IPG806: Pulsed-field ablation for atrial fibrillation. Last accessed October 2025.
2.    FARAPULSE Clinical compendium
3.    Boston Scientific data on file

Given the strength of evidence supporting catheter ablation for the treatment of AF in general and the need for effective rhythm control to delay progression, the European Society of Cardiology (ESC) now recommends catheter ablation for the treatment of selected AF patients, including as a first-line treatment strategy for paroxysmal AF (see table below).1 The ADVENT US IDE RCT, which demonstrated non-inferiority of FARAPULSE compared to thermal energy modalities in terms of efficacy and safety, is the only PFA-related study mentioned in the ESC guidelines.1,2

FIRST-LINE RHYTHM CONTROL THERAPY

Classa

Levelb

Catheter ablation is recommended as a first-line option with a shared decision-making rhythm control strategy in patients with paroxysmal AF (Atrial Fibrillation), to reduce symtoms, recurrence, and progression of AF.

1

A

AF PATIENTS RESISTANT OR INTOLERANT TO ANTIARRHYTHMIC DRUG THERAPY

Classa

Levelb

Catheter ablation is recommended in patients with paroxysmal or persistent AF resistant or intolerant to antiarrhythmic drug therapy to reduce symptoms, recurrence, and progression of AF.

1

A

PATIENTS WITH HEART FAILURE

Classa

Levelb

AF catheter ablation is recommended in patients with AF and HFrEF (Heart Failure with reduced Ejection Fraction) with high probability of tachycardia-induced cardiomyopathy to reverse left ventricular dysfunction.

1

B

Table adapted from Recommendation Table 18, 2024 ESC Guidelines for the Management of Atrial Fibrillation.1
 

a Class of recommendation

b Level of evidence

1.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176

2.    Reddy VY, Gerstenfeld EP, Natale A, et al, ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.    

In July 2025, NICE issued Interventional Procedure Guidance (IPG) on PFA for Atrial Fibrillation.1 The NICE guidance recommends PFA for AF with ‘standard arrangements’ which means that there is enough evidence for safety and efficacy. ‘Standard arrangement’ is the most positive of the four IPG recommendations available. PFA joins the recommendation category of other ablation modalities and gives physicians the autonomy to choose the best treatment option for their patients.

However, catheter ablation/Atrial Fibrillation is still proposed in the NICE guidelines for the treatment of AF (NG196) as a second-line treatment after drug therapy.2 This guidance dates from 2021 and does not align with more recent guidance from the ESC (2024)3 or the United States (2023)4 which both prioritise early rhythm control and support catheter ablation for the treatment AF as a first-line therapy in selected patients. Nonetheless, NICE guidance does recommend:

  • Offering patients a personalised package of care2
  • Referring promptly at any stage in treatment if it fails to control the symptoms and more specialised management is needed (within 4 weeks of failed treatment or recurrence of AF after cardioversion).2


1.    NICE Guidance IPG 806: Pulsed field ablation for atrial fibrillation (accessed July 2025)
2.    NICE Guideline NG196. Atrial fibrillation: diagnosis and management. April 2021, updated October 2021 available at https://www.nice.org.uk/guidance/ng196/chapter/ Recommendations (accessed October 2025)
3.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176
4.    Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149:e1–e156. doi: 10.1161/CIR.0000000000001193

Yes, for details of hospitals which offer FARAPULSE PFA, please visit our Treatment Centre Locator

Follow-up protocols after PFA can vary depending on the centre where the procedure is performed and individual patient needs. Generally, post-ablation care will include the following, as supported by ESC and NICE guidelines:1,2

  • Symptom assessment
  • Rhythm monitoring
  • Review of anticoagulation therapy
  • Review of antiarrhythmic drug requirements
     

1.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176
2.    NICE Guideline NG196. Atrial fibrillation: diagnosis and management. April 2021, updated June 2021 available at https://www.nice.org.uk/guidance/ng196/chapter/Recommendations (accessed April 2025)

FARAPULSE PFA is a treatment that can significantly reduce or even eliminate episodes of Atrial Fibrillation (AF) for many people.

Patients may be able to discontinue AADs following a successful PFA procedure with FARAPULSE, but decisions regarding discontinuation should be individualised, taking into account factors such as patient-specific risk factors, monitoring capabilities, and clinical judgment. In most cases, AADs are continued short-term to support rhythm stability during the early post-procedural period and then reassessed:

  • In the ADVENT RCT comparing FARAPULSE Pulsed Field Ablation with conventional thermal ablation, AADs were permitted during the initial 3-month blanking period but were required to be discontinued thereafter.1 Seven out of 10 people (73.3%) who had the FARAPULSE procedure remained off heart rhythm medications 1 year after the procedure.1
  • NICE Guidance advises offering AAD treatment for 3 months following ablation (with consideration for the patient’s preferences and risks and potential benefits), followed by a review to assess the need for continued use. 2 Similarly, 2024 ESC Guidelines acknowledge the role of short-term AAD therapy (2-3 months) post ablation to prevent early recurrence, with ongoing use determined by symptoms, rhythm status and shared decision-making.3
     

1.    Reddy VY, Gerstenfeld EP, Natale A, et al, ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.
2.    NICE Guideline NG196. Atrial fibrillation: diagnosis and management. April 2021, updated June 2021 available at https://www.nice.org.uk/guidance/ng196/chapter/Recommendations (accessed April 2025)
3.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176

 
 

NICE guidance advises that oral anticoagulation (OAC) therapy should not be discontinued solely because Atrial Fibrillation is no longer detectable. NICE recommends that any decisions regarding discontinuation should be made only after a comprehensive reassessment of stroke and bleeding risks, using validated tools like the CHA₂DS₂-VASc and ORBIT scores, and in consultation with the patient.1 Similarly, the 2024 ESC Guidelines recommend that all patients undergoing catheter ablation for Atrial Fibrillation (AF), including pulsed field ablation (PFA), should continue OAC for at least 2 months post-procedure, regardless of the ablation outcome. Long-term continuation of anticoagulation beyond this period should be based on the patient’s individual stroke risk profile, typically assessed using the CHA₂DS₂-VA score, rather than the apparent success of the ablation.2 For patients with non-valvular AF with a high stroke risk and contraindication to OAC, left atrial appendage (LAA) closure may offer an alternative to long-term anticoagulation and may be a preferred option for some patients.
Click here for more information on LAA closure with the WATCHMAN FLX device.
 

1.    NICE Guideline NG196. Atrial fibrillation: diagnosis and management. April 2021, updated June 2021 available at https://www.nice.org.uk/guidance/ng196/chapter/Recommendations (accessed April 2025)
2.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176

To manage symptoms, recurrence and the risk of progression if paroxysmal AF is not adequately managed, the 2024 European Society of Cardiology guidelines now recommend catheter ablation for selected AF patients — including as a first-line treatment for paroxysmal AF.1 While current NICE guidance continues to recommend antiarrhythmic drug therapy as first-line in the non-acute setting, it also advises that patients should be referred for specialist input within four weeks of treatment failure. Moreover, NICE stresses the need for a personalised package of care, which may include rhythm control strategies, such as pulmonary vein isolation (PVI) with catheter ablation.2

ESC Recommendations: Catheter Ablation1

FIRST-LINE RHYTHM CONTROL THERAPY

Classa

Levelb

Catheter ablation is recommended as a first-line option with a shared decision-making rhythm control strategy in patients with paroxysmal AF (Atrial Fibrillation), to reduce symtoms, recurrence, and progression of AF.

1

A

AF PATIENTS RESISTANT OR INTOLERANT TO ANTIARRHYTHMIC DRUG THERAPY

Classa

Levelb

Catheter ablation is recommended in patients with paroxysmal or persistent AF resistant or intolerant to antiarrhythmic drug therapy to reduce symptoms, recurrence, and progression of AF.

1

A

PATIENTS WITH HEART FAILURE

Classa

Levelb

AF catheter ablation is recommended in patients with AF and HFrEF (Heart Failure with reduced Ejection Fraction) with high probability of tachycardia-induced cardiomyopathy to reverse left ventricular dysfunction.

1

B

Table adapted from Recommendation Table 18, 2024 ESC Guidelines for the Management of Atrial Fibrillation.1

aClass of recommendation
bLevel of evidence

1.    Van Gelder IC, Rienstra M, Bunting KV, et al. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024;45(36):3314-3414. doi:10.1093/eurheartj/ehae176
2.    NICE Guideline NG196. Atrial fibrillation: diagnosis and management. April 2021, updated June 2021 available at https://www.nice.org.uk/guidance/ng196/chapter/Recommendations (accessed April 2025)

By referring your patient to a centre that offers FARAPULSE pulsed field ablation, you ensure they have access to a full range of treatment options — including the most advanced ablation technology currently available. Of course, the specialist you refer to will assess your patient’s suitability for ablation, ablation type and technology and discuss and agree with the patient the most appropriate treatment approach. To find a centre that offers FARAPULSE PFA, please click here.

While many centres around the world perform PFA with FARAPULSE under deep sedation, catheter ablation procedures are usually performed under general anaesthetic in the UK. Both methods have been proven save and effective.1
 

1.    Carboni L, Tondo C, Rossillo A, et al. Sedation protocols for atrial fibrillation ablation using pulsed-field ablation: patient and operator-reported outcomes from a large nationwide study. EP Europace 2025;27(S1). https://doi.org/10.1093/europace/euaf085.383

In the ADVENT RCT (designed as a non-inferiority trial), FARAPULSE PFA demonstrated non-inferiority for primary efficacy outcomes – including treatment success – compared to thermal ablation treatments (radiofrequency ablation or cryoballoon ablation).1

A recently published RCT demonstrated superiority in freedom from atrial tachyarrhythmias at 12 months with FARAPULSE PFA compared to cryoballoon ablation.2

Outcomes from these RCTs have been validated across several real-world trials.3-8

For more information on how FARAPULSE PFA compares to thermal ablation modalities, visit the Evidence section of this website

1.    Reddy VY, Gerstenfeld EP, Natale A, et al; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291.
2.    Reichlin T, Kueffer T, Badertscher P, et al. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025;392:1497-1507. doi: 10.1056/NEJMoa2502280
3.    Ekanem E, Neuzil, P, Reichlin T, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). doi:10.1038/s41591-024-03114-3.
4.    Schmidt B, Bordignon S, Nevenet K, et al. European real-world outcomes with pulsed field ablation in patients with symptomatic atrial fibrillation: Lessons from the multi-centre EU-PORIA Registry. Europace. 2023;25(7):euad185.
5.    Chaumont C, McDonnell E, Boveda S, et al. Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience. Arch Cardiovasc Dis. 2024;117(4):249-254. doi:10.1016/j.acvd.2024.01.005.
6.    Badertscher P, Weidlich S, Knecht S, et al. Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation. Europace 2023;25(12):euad329. doi: 10.1093/europace/euad329.
7.    Della Rocca DG, Marcon L, Magnocavallo M, et al. Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: A propensity scorematched comparison. Europace. 2023;26(1):euae016. doi: 10.1093/europace/euae016.
8.    Rattka M, Mavrakis E, Vlachopoulou D, et al. Pulsed field ablation and cryoballoon ablation for pulmonary vein isolation: Insights on efficacy, safety and cardiac function. J Interv Card Electrophysiol. 2024;67(5):1191-1198.

 

In general, 7-8 out of 10 patients are arrhythmia free at 12 months after an ablation procedure for paroxysmal AF.1-4 While it is true that an ablation procedure for pulmonary vein isolation may need to be repeated, FARAPULSE PFA has demonstrated non-inferiority in effectiveness compared to thermal ablation techniques.5 Five-year follow-up of first-in-human trials showed 81% freedom from recurrent atrial arrhythmia in patients treated with optimised biphasic PFA (73% for whole cohort) with FARAPULSE.6

A recent RCT has shown FARAPULSE PFA to offer superior freedom from atrial tachyarrhythmias at 12 months compared to cryoballoon ablation.7 In addition, FARAPULSE PFA shows consistently high rates of freedom from recurrence at one year across multiple real-world studies,8-14 with more evidence constantly building.

Real-world freedom from recurrence at one year in paroxysmal AF patients treated with FARAPULSE*
 

StudyN (patients)(%)
MANIFEST PF8102182%
EU PORIA974280%
Chaumont et al1016688%
Badertscher et al116574%
Della Rocca et al1217479%
Rattka et al135387%
FARADISE14753 80.8%

There is no randomised controlled trial data available on freedom from recurrence after FARAPULSE PFA treatment in persistent AF patients. The ADVANTAGE IDE study showed primary effectiveness event-free rate at 12 months of 73.4% in these patients, which is comparable to reported outcomes for paroxysmal AF. Real-world data show a slightly lower success rate than for paroxysmal AF.8-10,13,14*

Real-world freedom from recurrence at one year in persistent patients treated with FARAPULSE*
 

StudyN (patients)(%)
MANIFEST PF854772%
EU PORIA945766%
Chaumont et al1011088%
Rattka et al132887%
FARADISE14**40167.7%

*Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.
**Non-paroxysmal AF (incl. persistent and long- standing persistent AF)

When choosing the ablation modality to use for the treatment of AF, electrophysiologists consider the safety profile, effectiveness and the reproducibility of each technology, together with the patient experience. It is based on these parameters that PFA – and the FARAPULSE System as the pioneering PFA technology – have gained such rapid adoption around the world.

1.    Wazni OM, Dandamudi G, Soood N, et al., STOP AF First Trial Investigators. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. N Engl J Med. 2021;384(4):316-324. doi: 10.1056/NEJMoa2029554
2.    Kuniss M, Pavlovic N, Velagic V, et al., Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021;23(7):1033-1041. doi: 10.1093/europace/euab029
3.    Turagam MK, Musikantow D, Whang W, et al. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials. JAMA Cardiol. 2021 Jun 1;6(6):697-705. doi: 10.1001/jamacardio.2021.0852.
4.    Imberti JF, Ding WY, Kotalczyk A, et al. Catheter ablation as first-line treatment for paroxysmal atrial fibrillation: a systematic review and meta-analysis. Heart. 2021;107(20):1630-1636. doi: 10.1136/heartjnl-2021-319496.
5.    Reddy VY, Gerstenfeld EP, Natale A, et al; ADVENT Investigators. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2023;389(18):1660-1671. doi: 10.1056/NEJMoa2307291
6.    Musikantow D, Neuzil P, Anic A, et al. Long-Term Clinical Outcomes of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation. J Am Coll Cardiol EP; 9(9):2001–2003. doi: 10.1016/j.jacep.2023.06.019.
7.    Reichlin T, Kueffer T, Badertscher P, et al. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025;392:1497-1507. doi: 10.1056/NEJMoa2502280
8.    Ekanem E, Neuzil, P, Reichlin T, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024). doi:10.1038/s41591-024-03114-3.
9.    Schmidt B, Bordignon S, Nevenet K, et al. European real-world outcomes with pulsed field ablation in patients with symptomatic atrial fibrillation: Lessons from the multi-centre EU-PORIA Registry. Europace. 2023;25(7):euad185.
10.    Chaumont C, McDonnell E, Boveda S, et al. Prospective 1-year results of atrial fibrillation ablation using the pentaspline pulsed field ablation catheter: The initial French experience. Arch Cardiovasc Dis. 2024;117(4):249-254. doi:10.1016/j.acvd.2024.01.005.
11.    Badertscher P, Weidlich S, Knecht S, et al. Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation. Europace 2023;25(12):euad329. doi: 10.1093/europace/euad329.
12.    Della Rocca DG, Marcon L, Magnocavallo M, et al. Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: A propensity scorematched comparison. Europace. 2023;26(1):euae016. doi: 10.1093/europace/euae016.
13.    Rattka M, Mavrakis E, Vlachopoulou D, et al. Pulsed field ablation and cryoballoon ablation for pulmonary vein isolation: Insights on efficacy, safety and cardiac function. J Interv Card Electrophysiol. 2024;67(5):1191-1198.
14.    Boersma, L. V. A., Széplaki, G., Dello Russo, A., García-Bolao, I., Efremidis, M., Szegedi, N., Willems, S., Haqqani, H., Gandjbakhch, E., Solimene, F., et al. (2025). Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry. EP Europace, 27(9), euaf182. https://doi.org/10.1093/europace/euaf182

There are number of resources available for patients who have Atrial Fibrillation and may be suitable for a pulmonary vein isolation with FARAPULSE PFA. These include a patient website with downloadable leaflets on treatment options, what to expect from the FARAPULSE PFA procedure and a guide to healthy living.

The FARAPULSE PFA System received CE Mark approval in Europe in 2021. Globally, 500,000 patients have now been treated with FARAPULSE PFA in just over three years of commercialisation.1

1.    Data on file. Boston Scientific.

The first FARAPULSE PFA procedure was performed at the Royal Papworth Hospital in Cambridge in June 2022, as reported here.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.