A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
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A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-PV Sources Utilizing Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall in Persistent Atrial Fibrillation Patients.
1 other identifier
interventional
699
7 countries
41
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedStudy Start
First participant enrolled
November 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 28, 2026
May 1, 2026
2.6 years
September 15, 2025
May 26, 2026
Conditions
Keywords
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 COMPARATORPVI + 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.
Treatment Arm
EXPERIMENTALPVI + 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.
Interventions
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.
An electrophysiology mapping system that uses a proprietary algorithm to analyze electrogram signals.
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.
Eligibility Criteria
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
- +48 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Banner University Medical Center
Phoenix, Arizona, 85008, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Alta Bates Summit Medical Center-Hospital
Oakland, California, 94609, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204, United States
Piedmont Athens Regional
Athens, Georgia, 30606, United States
Emory University Hospital
Atlanta, Georgia, 30308, United States
St. Luke's Boise Medical Center
Boise, Idaho, 83702, United States
Endeavor Hospital
Glenview, Illinois, 60026, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, 50266, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center-Hospital
Boston, Massachusetts, 02215, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, 55805, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Good Samaritan - Suffern
Suffern, New York, 10901, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, 97477, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Presbyterian University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, 75701, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
AZORG
Aalst, 9300, Belgium
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt, 3500, Belgium
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
Rouen, 76000, France
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, 60431, Germany
Prince of Wales Hosptial
Shatin, Hong Kong, Hong Kong
St. Antonius Ziekenhuis
Nieuwegein, 3435, Netherlands
Erasmus MC - University Medical Center Rotterdam
Rotterdam, 3015, Netherlands
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
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
May 28, 2026
Record last verified: 2026-05