Actively Recruiting
A Global Randomized Trial Comparing Pulsed Field Ablation of Pulmonary Veins Plus Extra-Pulmonary Vein Sources Using Electrographic Flow Mapping Versus Pulmonary Veins Plus Posterior Wall Ablation in Persistent Atrial Fibrillation Patients
Led by Boston Scientific Corporation · Updated on 2026-05-28
699
Participants Needed
41
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of pulsed field ablation (PFA) therapy for treating persistent atrial fibrillation (PersAF) that does not respond to medication. This study compares two approaches: PFA targeting the pulmonary veins plus electrographic flow (EGF) identified extra-pulmonary vein sources, and PFA targeting the pulmonary veins plus the left atrial posterior wall. The goal is to see if the new method with EGF mapping is at least as effective as the standard approach in managing symptoms of PersAF. Participants will be randomly assigned to one of two groups. The control group will receive pulmonary vein isolation (PVI) plus posterior wall ablation (PWA) using PFA, with EGF mapping performed but not used for treatment decisions. The treatment group will receive PVI plus ablation of active sources identified by EGF mapping. The FARAPOINT catheter may be used for narrow posterior wall channels if found. All subjects will undergo mapping and ablation with devices including the FARAPULSE PFA system and Opal HDx mapping system. Ablation procedures and mapping will be performed according to protocol. During the study, participants will be monitored for safety up to 60 days and effectiveness up to 365 days after treatment. Follow-up will include assessments to track heart rhythm and symptoms, with the use of a LUX-Dx insertable cardiac monitor for continuous monitoring. Participants must be able to comply with follow-up visits and device usage instructions. The study aims to capture data on safety outcomes and measure how well the ablation controls atrial fibrillation over one year.
CONDITIONS
Brief Title
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older (or as required by local law)
- Symptomatic drug-refractory persistent atrial fibrillation lasting more than 7 days and up to 365 days
- Documentation confirming continuous atrial fibrillation via ECG or 24-hour ECG recording within 180 days
- Willing and able to provide informed consent
- Willing and able to participate in all follow-up visits and testing at an approved center
- Willing to receive or already have a LUX-Dx insertable cardiac monitor inserted within 6 months of consent
You will not qualify if you...
- Left atrial diameter 5.5 cm or larger, or volume over 100 ml if diameter not available
- Prior left atrial ablation or atrial surgery
- Current atrial myxoma or left atrial thrombus
- Pulmonary vein abnormalities, stenosis, or stenting (except common and middle veins)
- History of sustained ventricular tachycardia or ventricular fibrillation
- Severe right ventricular dysfunction
- Atrial fibrillation due to reversible causes like electrolyte imbalance or thyroid disease
- Presence or planned implantation of certain cardiac devices excluding LUX-Dx
- Significant valvular heart disease including prosthetic valves or moderate to severe mitral valve issues
- Hypertrophic or amyloid cardiomyopathy
- Contraindications to femoral access or planned cardiac surgery within 12 months
- Heart failure NYHA Class III or IV or left ventricular ejection fraction below 40%
- BMI above 45.0
- Known bleeding disorders or unwillingness to use anticoagulation
- Pregnancy or lactation at time of procedure
- Severe lung disease or pulmonary hypertension
- Active malignancy other than certain skin cancers
- Significant gastrointestinal or systemic infections
- Untreated severe sleep apnea
- Life expectancy less than one year
- Participation in other investigational studies interfering with this trial
- Recent major cardiac events or interventions within 90 days
- Uncontrolled hypertension or high stroke risk score
- Known allergy to nitroglycerin
- Unwillingness or inability to tolerate LUX-Dx cardiac monitor
- Certain congenital heart diseases or blood disorders
- History of organ transplant or serious cardiac or renal conditions
- Any condition that may interfere with study participation or data interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo electroanatomical mapping of the left atrium followed by pulsed field ablation or posterior wall ablation depending on their assigned treatment arm.
1 procedure visit (in-person)
Duration - Up to 365 days
Participants are monitored for safety and effectiveness of the ablation procedure over time.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 41 locations
1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
Not Yet Recruiting
2
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Not Yet Recruiting
3
Banner University Medical Center
Phoenix, Arizona, United States, 85008
Not Yet Recruiting
4
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
5
Alta Bates Summit Medical Center-Hospital
Oakland, California, United States, 94609
Actively Recruiting
6
Stanford University Medical Center
Palo Alto, California, United States, 94304
Not Yet Recruiting
7
Pacific Heart Institute
Santa Monica, California, United States, 90404
Actively Recruiting
8
St. Vincent's Medical Center
Jacksonville, Florida, United States, 32204
Not Yet Recruiting
9
Piedmont Athens Regional
Athens, Georgia, United States, 30606
Not Yet Recruiting
10
Emory University Hospital
Atlanta, Georgia, United States, 30308
Actively Recruiting
11
St. Luke's Boise Medical Center
Boise, Idaho, United States, 83702
Actively Recruiting
12
Endeavor Hospital
Glenview, Illinois, United States, 60026
Not Yet Recruiting
13
Mercy Hospital Medical Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
14
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Not Yet Recruiting
15
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
16
Beth Israel Deaconess Medical Center-Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
17
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Not Yet Recruiting
18
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States, 55805
Not Yet Recruiting
19
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
20
Good Samaritan - Suffern
Suffern, New York, United States, 10901
Not Yet Recruiting
21
Mission Hospital
Asheville, North Carolina, United States, 28801
Not Yet Recruiting
22
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
23
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
24
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
25
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, United States, 97477
Withdrawn
26
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
27
Presbyterian University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
28
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
29
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
30
Christus Trinity Mother Frances Health System
Tyler, Texas, United States, 75701
Actively Recruiting
31
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Withdrawn
32
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Not Yet Recruiting
33
AZORG
Aalst, Belgium, 9300
Actively Recruiting
34
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt, Belgium, 3500
Actively Recruiting
35
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
Rouen, France, 76000
Not Yet Recruiting
36
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, Germany, 60431
Actively Recruiting
37
Prince of Wales Hosptial
Shatin, Hong Kong, Hong Kong
Actively Recruiting
38
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
Not Yet Recruiting
39
Erasmus MC - University Medical Center Rotterdam
Rotterdam, Netherlands, 3015
Actively Recruiting
40
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Not Yet Recruiting
41
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
J
Jackie Lin
K
Karin Froidcourt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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