Who is eligible for clinical trial NCT06096337?

Participants must meet protocol criteria for Persistent Atrial Fibrillation. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06096337 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-26

Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation (NCT06096337)

🔵 Active, Not Recruiting Observational / Diagnostic 💊 Investigational Drug / Biologic Sponsor: Boston Scientific Corporation

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (60 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥ 18 years of age, or older if specified by local law
Have symptomatic persistent AF, confirmed by both: a. Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart b. Documentation, such as physician note, of persistent continuous AF for \> 7 days and ≤ 365 days
Willing and capable of providing informed consent
Willing and capable of participating in all 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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Treated with AAD (Class I or III) ≤ 6 months (i.e., within 180 days) before enrollment,
More than 7-day history of therapeutic AAD use (Class I or III), or
≥ 24 hours amiodarone, i Note Pill-in-the-pocket AAD use, is permitted.
Treated with AAD ( Class I or III) \> 6 months (i.e., more than 180 days) before enrollment and experienced AAD failure (adverse drug effects or frequent AF episodes)
Contraindication to, or unwillingness to use, AADs (Class I and III, excluding amiodarone)
Contraindication to PFA treatment
Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra-, and post-procedure to achieve adequate anticoagulation.
Any of the following atrial conditions:
Left atrial (LA) anteroposterior diameter ≥ 5.5 cm, or, if LA diameter not available, non-indexed volume \>100 ml, as documented by physician note or imaging (Note: if both values are available, only the LA diameter will be used to confirm eligibility criteria)
Any prior atrial endocardial, epicardial or surgical ablation procedure for arrhythmia, other than right sided cavotricuspid isthmus ablation or for right sided supraventricular tachycardia
Current atrial myxoma

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (61 Sites)

University of Alabama at Birmingham — Birmingham, Alabama
Banner University Medical Center Phoenix — Phoenix, Arizona
Phoenix Cardiovascular Research Group — Phoenix, Arizona
Arrhythmia Research Group — Jonesboro, Arkansas
Scripps Memorial Hosptial — La Jolla, California
Stanford University Medical Center — Palo Alto, California
Cardiology Associates Medical Group, Inc — Ventura, California
HCA Florida Mercy Hospital — Miami, Florida
Sarasota Memorial Hospital — Sarasota, Florida
Tallahassee Memorial Hospital — Tallahassee, Florida
St. Joseph's Hospital — Tampa, Florida
Emory University Hospital — Atlanta, Georgia
Memorial Health University Medical Center — Savannah, Georgia
St. John's Hospital — Springfield, Illinois
Community Heart and Vascular Hospital — Indianapolis, Indiana
Mercy Hospital Medical Center-Hospital — West Des Moines, Iowa
Baptist Health Lexington — Lexington, Kentucky
Johns Hopkins Hospital — Baltimore, Maryland
Brigham and Women's Hospital — Boston, Massachusetts
Southcoast Physicians Group — Fall River, Massachusetts
University of Michigan Hospitals — Ann Arbor, Michigan
Corewell Health — Grand Rapids, Michigan
Mayo Clinic Foundation-Hospital — Rochester, Minnesota
Catholic Medical Center — Manchester, New Hampshire
Valley Hospital — Paramus, New Jersey

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗