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ATRIAL FIBRILLATION

Persistent AF

Key trials exploring the role of FARAPULSE PFA

ADVANTAGE25,26

Prospective Multi-Centre Single-Arm Trial on Drug-Refractory, Symptomatic Persistent AF Patients

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

ADVANTAGE21,22

Prospective Multi-Centre Single-Arm Trial on Drug-Refractory, Symptomatic Persistent AF Patients (2 Phases):

View phase 1 data sheet
View phase 2 data sheet
Discover the number of patients treated in key clinical trials.

Patients #

515 across two phases:

  • 260 Phase I
  • 255 phase II
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Patient Population

Persistent AF (PVI + PWA)

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Location

International (49 sites)

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Study Goal & Design

Goal:

  • Phase I: IDE study to establish the safety and effectiveness of PVI+PWA using FARAWAVE
  • Phase II: IDE study to establish:
    • Safety and effectiveness of PVI+PWA using FARAWAVE catheter
    • Safety and effectiveness of CTI ablation using FARAPOINT focal-linear PFA catheter

Design:

  • Multicentre
  • Prospective
  • Single-arm
  • Open-label
  • Monitoring with ICM (Phase 2)
Boston Scientific drives PFA leadership with key findings and clinical trials for FARAPULSE™ in atrial fibrillation.

Key findings

  • Primary safety and efficacy endpoints were met
  • No reports of:
    • Stroke
    • PV stenosis
    • Oesophageal fistula
    • Pericardial tamponade
    • Major vascular access complication
  • Primary safety event rate 2.4%
  • Primary effectiveness event-free rate at 12 months comparable to paroxysmal AF reported outcomes (73.4%)*
  • 96.4% of patients treated with CTI line ablation with FARAPOINT had no recurrence of AFL

AF: Atrial fibrillation; AFL: Atrial flutter; CTI: Cavotricuspid isthmus; ICM: Implantable cardiac monitor; PAF: Persistent atrial fibrillation; PFA: Pulsed field ablation; PV: Pulmonary vein; PVI: Pulmonary vein isolation; PWA: Posterior wall ablation.
*Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.

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