Actively Recruiting
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
Led by Boston Scientific Corporation · Updated on 2026-05-05
699
Participants Needed
39
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 as required by local law
- Symptomatic drug-refractory persistent atrial fibrillation confirmed by continuous AF lasting more than 7 days and up to 365 days
- Documentation within 180 days before enrollment of continuous AF by 24-hour ECG or two ECGs at least 7 days apart
- Ability and willingness to provide informed consent
- Ability and willingness to participate in all follow-up assessments and testing at an approved clinical center
- Willingness to receive or already having a LUX-Dx insertable cardiac monitor inserted within 6 months and comply with transmission instructions
You will not qualify if you...
- Left atrial anteroposterior diameter equal to or greater than 5.5 cm or non-indexed volume greater than 100 ml
- Any prior left atrial ablation or atrial surgery
- Current atrial myxoma or left atrial thrombus
- Pulmonary vein abnormality, stenosis, or stenting (except common and middle pulmonary veins)
- History of sustained ventricular tachycardia or ventricular fibrillation
- Severe right ventricular dysfunction
- Atrial fibrillation caused by reversible or non-cardiac causes such as electrolyte imbalance or thyroid disease
- Presence of cardiac devices like pacemakers, implantable defibrillators, loop recorders other than LUX-Dx, or left atrial appendage closure devices
- Significant valvular heart conditions including prosthetic valves or moderate to severe mitral stenosis or regurgitation
- Hypertrophic or amyloid cardiomyopathy
- Any inferior vena cava filter or contraindication to femoral access
- Planned cardiac surgery or transplantation within 12 months
- Heart failure with NYHA Class III or IV
- Left ventricular ejection fraction less than 40%
- Body mass index over 45
- Known bleeding disorders or contraindication to systemic anticoagulation
- Pregnant or lactating women at the time of ablation
- Severe lung disease or pulmonary hypertension requiring oxygen
- Active malignancy except squamous cell carcinoma
- Significant gastrointestinal problems involving the esophagus or stomach
- Active systemic infection
- Untreated severe obstructive sleep apnea
- Life expectancy less than one year
- Current enrollment in conflicting investigational studies
- Use of phosphodiesterase inhibitors within 24 hours before ablation
- Uncontrolled hypertension
- High stroke risk score (CHA2DS2-VASc of 5 or more)
- Known allergy to nitroglycerin (excluding hypotension)
- Unwillingness or inability to tolerate LUX-Dx cardiac monitor
- Congenital heart disease with significant abnormalities
- History of congenital methemoglobinemia or G6PD deficiency
- History of solid organ or hematologic transplant or evaluation for transplant
- History of hemi-diaphragmatic paralysis or paresis
- History of Prinzmetal Angina or severe non-revascularizable coronary disease
- Renal insufficiency with eGFR less than 30 or history of dialysis or transplant
- Any other condition that would increase risk or interfere with the study
- Recent (within 90 days) myocardial infarction, unstable angina, cardiac surgery, heart failure hospitalization, pericarditis, gastrointestinal bleeding, stroke or thromboembolic events, carotid interventions, uncontrolled diabetes with HbA1c over 8%
AI-Screening
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Trial Site Locations
Total: 39 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
Not Yet 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
Not Yet 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
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Not Yet Recruiting
17
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States, 55805
Not Yet Recruiting
18
Mount Sinai Medical Center
New York, New York, United States, 10029
Not Yet Recruiting
19
Good Samaritan - Suffern
Suffern, New York, United States, 10901
Not Yet Recruiting
20
Mission Hospital
Asheville, North Carolina, United States, 28801
Not Yet Recruiting
21
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
23
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Not Yet Recruiting
24
Sacred Heart Medical Center at Riverbend
Springfield, Oregon, United States, 97477
Withdrawn
25
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
26
Presbyterian University of Pennsylvania Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
27
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
28
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
29
Christus Trinity Mother Frances Health System
Tyler, Texas, United States, 75701
Actively Recruiting
30
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Withdrawn
31
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Not Yet Recruiting
32
AZORG
Aalst, Belgium, 9300
Actively Recruiting
33
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt, Belgium, 3500
Actively Recruiting
34
Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle
Rouen, France, 76000
Not Yet Recruiting
35
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt, Germany, 60431
Not Yet Recruiting
36
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
Not Yet Recruiting
37
Erasmus MC - University Medical Center Rotterdam
Rotterdam, Netherlands, 3015
Not Yet Recruiting
38
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain, 08036
Not Yet Recruiting
39
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
J
Jackie Lin
CONTACT
K
Karin Froidcourt
CONTACT
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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