Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
Condition(s) studied
Investigational drug(s) / intervention(s)
FARAPULSE™ Pulsed Field Ablation (PFA) System: Subjects will undergo a pulsed field ablation procedure using the FARAPULSE™ Pulsed Field Ablation (PFA) System for the isolation of pulmonary veins and posterior wall.
Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone: Anti-Arrhythmic Drugs (AADs) including, Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone will be prescribed and monitored in accordance with local clinical practice and already established guideline-directed therapy for patients with persistent atrial fibrillation (AF).
Study summary
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.
Eligibility
Primary outcome measure(s)
- Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious. — 12-Months
Defined Composite Adverse Events: Day 0 through Day 7: * Gastric motility / pyloric spasm disorders * Heart block * Myocardial infarction * Peripheral or organ thromboembolism * Pulmonary edema * Stroke/ Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Unresolved phrenic nerve palsy / paresis * Vascular access complications Day 0 through Day 30: * Cardiac tamponade / perforation * Cardiovascular or pulmonary adverse event * Death * Pericarditis Day 0 through Month 12: * Atrio-esophageal fistula * Pulmonary vein stenosis - Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment. — 12-Months
Defined Treatment Success: PFA and AAD Treatment Arms: • Amiodarone freedom from randomization to Month 12 unless previously an acute or chronic primary effectiveness failure. PFA Treatment Arm: • Acute Success - Isolation of attempted pulmonary veins and left atrial posterior wall during blanking period with PFA system And Chronic Success: Freedom during blanking period to Month 12 of: * Occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachycardia (AT) * Any re-ablation for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III AAD use AAD Treatment Arm: Acute Success - Ablation not performed in blanking period Chronic Success - Freedom after blanking period through Month 12 of: * Detectable occurrence ≥ 1 hr of asymptomatic or ≥ 30 sec of symptomatic AF, AFL, or AT * Electrical cardioversion for AF, AFL, or AT * Any ablation for AF, AFL, or AT
Trial sites (61)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Northwell Health | Bay Shore | New York | |
| Kaleida Health | Buffalo | New York | |
| Weill Cornell Medical University | New York | New York | |
| Good Samaritan - Suffern | Suffern | New York | |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | |
| Bethesda North Hospital | Cincinnati | Ohio | |
| Cleveland Clinic | Cleveland | Ohio | |
| OhioHealth Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio | |
| Oklahoma Heart Institute | Tulsa | Oklahoma | |
| York Hospital | York | Pennsylvania | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| University of Texas Medical Branch | Galveston | Texas | |
| Orion Medical | Houston | Texas | |
| Christus Trinity Mother Frances Health System | Tyler | Texas | |
| Intermountain Medical Center | Murray | Utah |
+ 21 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06096337 on ClinicalTrials.gov ↗ ← All trials in Belgium