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ATRIAL FIBRILLATION

Paroxysmal AF

Key trials exploring the role of FARAPULSE PFA

IMPULSE, PEFCAT, PEFCAT II20,21

First-In-Human Trials

Discover the number of patients treated in key clinical trials.
121 patients
Key findings

ADVENT22,23

Randomised Controlled Trial (RCT) Comparing FARAPULSE PFA with Thermal Energy Ablation

Discover the number of patients treated in key clinical trials.
607 patients
Key findings

SINGLE SHOT CHAMPION27

Comparison of Cryoballoon vs Pulsed Field Ablation in Paroxysmal AF (RCT)

Discover the number of patients treated in key clinical trials.
121 patients
Key findings

IMPULSE, PEFCAT, PEFCAT II20,21

First-In-Human (FIH) Trials: IMPULSE: FIH safety and feasibility, monophasic and biphasic I waveforms
PEFCAT: FIH safety and feasibility, biphasic I & II waveforms
PEFCAT II: FIH expanded safety and feasibility, biphasic II waveform

Discover the number of patients treated in key clinical trials.

Patients #

121

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Patient Population

Paroxysmal AF (PVI)

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Location

Croatia (PEFCAT II) | Czech Republic | (IMPULSE, PEFCAT, PEFCAT II) | France (IMPULSE, PEFCAT)

Checklist clipboard with pen icon, representing study goals and design for Boston Scientific’s clinical research and PFA leadership.

Study Goal & Design

Goal: Find the optimised waveform with highest efficacy and safety outcomes

Design:

  • Multicentre
  • Prospective
  • Single-arm
  • Safety and feasibility
  • Prospective remapping was performed in 110 patients at 2-3 months post-procedure
Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • Acute PVI achieved in 100% PVs
  • Durable PVI achieved in 96% of PVs treated with optimised biphasic PFA (84% for all PVs)
  • 1-year Kaplan Meier estimate freedom from any atrial arrythmia: 84.5% patients treated with optimised biphasic PFA (78.5% for whole cohort)
  • 5-year follow up showed 81% freedom from recurrent atrial arrhythmias in patients treated with optimised biphasic PFA (73% for whole cohort)21

AF: Atrial fibrillation; FIH: First in human; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation

ADVENT25,26 US IDE TRIAL

Randomised Controlled Trial Comparing
FARAPULSE PFA with Thermal Energy

View data sheet
Discover the number of patients treated in key clinical trials.

Patients #

607

Three people connected under a globe symbolising the patient population.

Patient Population

Paroxysmal AF (PVI)

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Location

USA

Checklist clipboard with pen icon, representing study goals and design for Boston Scientific’s clinical research and PFA leadership.

Study Goal & Design

Goal: Establish Non-inferiority of the FARAPULSE PFA system to standard of care (thermal ablation) in terms of safety and effectiveness

Design:

  • Multicentre
  • Prospective
  • Blinded randomised (1:1) controlled trial
Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • Composite primary effectiveness 73.3% in PFA arm vs. 71.3% in thermal arm
  • Non-inferiority in terms of safety and effectiveness
  • Significantly less pulmonary vein cross-sectional narrowing
  • Significantly shorter procedure times
  • Zero reported strokes
  • Sequential sub-abalysis showed fewer atrial arrhythmia episodes, potentially resulting in better quality of life, lower risk for re-do ablation, cardioversion and hospitalisation23

AF: Atrial fibrillation; FIH: First in human; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation

SINGLE-SHOT CHAMPION27

Comparison of Cryoballoon vs Pulsed field Ablation in Paroxysmal AF

View data sheet
Discover the number of patients treated in key clinical trials.

Patients #

210 (PVI)

Three people connected under a globe symbolising the patient population.

Patient Population

Symptomatic, drug-refrectory paroxysmal AF

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Location

Switzerland

Checklist clipboard with pen icon, representing study goals and design for Boston Scientific’s clinical research and PFA leadership.

Study Goal & Design

Goal: Establish non-inferiority of the FARAPULSE PFA vs. Arctic Front™ Advance Cryoballoon

Design:

  • Multicentre
  • Prospective
  • Randomised-controlled trial (1:1), blinded endpoint adjudication
  • Continuous monitoring of AA burden post ablation with ICM
Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • The overall major AE rates were very low, 1% in FARAPULSE patients
  • FARAPULSE significantly reduced AA recurrence – 13.6% reduction vs. Arctic Front
  • Comparable outcomes in clinical interventions and quality of life
  • FARAPULSE procedures were 18 minutes shorter on average

AF: Atrial fibrillation; FIH: First in human; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation

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