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NCT06096337 · ClinicalTrials.gov registry record · NA
Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
A NA study of Persistent Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- NA
- Development phase
- 484
- Enrollment target
- 20
- Study locations
NCT06096337: Active NA study of Persistent Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT06096337 is a NA study of Persistent Atrial Fibrillation that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 484 participants, below the 1,228-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096337, a NA study of Persistent Atrial Fibrillation, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 484 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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: * A
Conditions Studied
Interventions
- DEVICE FARAPULSE™ Pulsed Field Ablation (PFA) System
- DRUG Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone
Study Locations (20)
Florida
- HCA Florida Mercy Hospital - Miami
- Sarasota Memorial Hospital - Sarasota
- Tallahassee Memorial Hospital - Tallahassee
- St. Joseph's Hospital - Tampa
California
- Scripps Memorial Hosptial - La Jolla
- Stanford University Medical Center - Palo Alto
- Cardiology Associates Medical Group, Inc - Ventura
Arizona
- Banner University Medical Center Phoenix - Phoenix
- Phoenix Cardiovascular Research Group - Phoenix
Georgia
- Emory University Hospital - Atlanta
- Memorial Health University Medical Center - Savannah
Massachusetts
- Brigham and Women's Hospital - Boston
- Southcoast Physicians Group - Fall River
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- Arrhythmia Research Group - Jonesboro
Illinois
- St. John's Hospital - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 484 participants |
| Start Date | 2023-12-28 |
| Est. Completion | 2028-02-04 |
| Phase | NA |
What the registry record for NCT06096337 still lists
NCT06096337 is an interventional study that assigns participants to a tested intervention. The registered 484 participants enrollment target is mid-sized for trials with a published cap, below the 1,228-participant average among 15 other Persistent Atrial Fibrillation trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Persistent Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which FARAPULSE™ Pulsed Field Ablation (PFA) System is the first listed.
NCT06096337 names 20 study sites across 12 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06096337 about?
NCT06096337 is a clinical study titled "Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation". 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.
What is the current status of trial NCT06096337?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 484 participants. The study started on 2023-12-28. Estimated completion is 2028-02-04.
What conditions does trial NCT06096337 study?
This clinical trial studies the following conditions: Persistent Atrial Fibrillation.
What interventions are being tested in trial NCT06096337?
The interventions under investigation include: FARAPULSE™ Pulsed Field Ablation (PFA) System (DEVICE), Anti-Arrhythmic Drug (AAD): Flecainide, Sotalol, Propafenone, Dofetilide, and Dronedarone (DRUG).
Who is sponsoring clinical trial NCT06096337?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096337 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Persistent Atrial Fibrillation
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Where NCT06096337's enrollment target sits among peer trials
484 3rd of 15 higher than 13 of 15 other Persistent Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Persistent Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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