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

NCT07187115 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PF334
• Study Type: interventional
• Target: 699
• Locations: 4 countries
• Sites: 15

Brief Summary

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).

Conditions

Persistant Atrial Fibrillation; Atrial Fibrillation (AF)

Keywords

FARAPULSE; FARAPOINT; OptiMap

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  The primary safety endpoint is the rate of ITT subjects in the PVI+EGF arm with one or more of the following serious device- or procedure-related Composite Adverse Events (CAEs) assessed through 60 days following the Index Procedure.

  60 Days

• Primary Effectiveness Endpoint

  The primary effectiveness endpoint is the rate of ITT subjects with treatment success in the PVI+EGF arm vs. the PVI+PWA control arm through Day 365, aiming to demonstrate non-inferiority of PVI+EGF compared to the PVI+PWA control.

  365 Days

Secondary Outcomes (1)

• Secondary Effectiveness Endpoint

  365 Days

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

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.

Device: OptiMap System (non-ablative); Device: FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System

Treatment Arm

EXPERIMENTAL

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.

Device: FARAPOINT Pulsed Field Ablation System; Device: OptiMap System (non-ablative); Device: FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System

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.

Treatment Arm

OptiMap System (non-ablative) DEVICE

An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.

Also known as: Ablamap System

Control Arm; Treatment Arm

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.

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age, or older if required by local law
• Have symptomatic drug-refractory1, persistent AF2, confirmed by both:
• Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days and the arrhythmia symptoms
• Documentation, within 180 days of enrollment date of either:
• A 24-hour continuous ECG recording confirming continuous AF or
• Two (2) ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
• Willing and capable of providing informed consent
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center
• Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

You may not qualify if:

• Any of the following atrial conditions:
• Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume \>100 ml (physician note or imaging)
• Any prior left atrial ablation
• Any prior atrial surgery
• Current atrial myxoma
• Current left atrial thrombus
• Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data, per Investigator's discretion
• AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
• Cardiac devices and implants:
• Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
• Implantable loop recorder, other than LUX-Dx
• Interatrial baffle, patent foramen ovale or atrial septal defect closure device or patch

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (15)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Piedmont Athens Regional

Athens, Georgia, 30606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

St. Luke's Boise Medical Center

Boise, Idaho, 83702, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

AZORG

Aalst, 9300, Belgium

Location

Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Prince of Wales Hosptial

Shatin, Hong Kong, Hong Kong

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The investigators and staffs will be blinded to the EGF maps in Control Arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: plus non-randomized cohorts (Attempt, Roll-in)

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

HK (1); US (11); BE (2); ES (1)