A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

Conditions

• Atrial Fibrillation (AF)
• Persistant Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FARAPOINT Pulsed Field Ablation System — DEVICE
  A component of the FARAPULSE Pulsed Field Ablation (PFA) System and is a multi-electrode bidirectional, deflectable percutaneous catheter, an adjunctive catheter designed to create focal-type lesions for the creation of an ablation line between the inferior vena cava and the tricuspid valve.
• OptiMap System (non-ablative) — DEVICE
  An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.
• FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System — DEVICE
  All subjects will undergo electroanatomical mapping of the entire left atrium with the FARAWAVE NAV Catheter and Opal HDx Mapping System, followed by PFA PVI with the FARAWAVE NAV PFA Catheter, per the instructions of use.

Study Details

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

Key Dates

Start date

Nov 7, 2025

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Dec 31, 2030

Study Design

Enrollment

699 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control Arm
  PVI + PWA: The Control Arm, consisting of subjects undergoing PVI + PWA. PWA will be performed adjunctive to PVI per protocol Section 10.8.10. Following confirmation of PWA, EGF mapping will be performed in the LA and RA, while Investigators, lab/nursing staff, and research personnel are blinded to the EGF maps.
• Experimental: Treatment Arm
  PVI + EGF source(s) ablation: The Treatment Arm, consisting of subjects undergoing PVI + EGF source(s) ablation. Adjunctive to PVI, the EGF-identified active sources above threshold will be ablated per protocol Section 10.8.11. If following PVI, a narrow channel that is approximately ≤ 1 cm is identified in the LAPW, ablation may be performed using the FARAPOINT Catheter.

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 60 Days ]

Central Contacts

• Jackie Lin
  +16123608544
  [email protected]
• Karin Froidcourt
  +32 471 63 6566
  [email protected]

Locations (32)

Find similar trials in Birmingham, AL

Related Studies

• KardiaMobile ECG Monitoring Effects on Health Care Utilization and Patient Experience With Atrial Fibrillation
  Enrolling By Invitation · Northwestern University · Chicago, Illinois
• Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
  PHASE3 · Recruiting · Anthos Therapeutics, Inc. · Birmingham, Alabama
• Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
  EARLY_PHASE1 · Recruiting · China National Center for Cardiovascular Diseases · Boston, Massachusetts
• Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation
  Recruiting · University of California, San Francisco · San Francisco, California