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NCT05443594 · ClinicalTrials.gov registry record · NA
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 669
- Enrollment target
NCT05443594: Completed NA study, sponsored by Boston Scientific Corporation.
NCT05443594 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 669 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05443594, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 669 participants
- Enrollment target
Study Summary
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).
Primary Outcome
Phase 1: Through 7 Days: * Myocardial infarction * Stroke * Transient Ischemic Attack (TIA) * Peripheral or organ thromboembolism * Pulmonary edema * Unresolved phrenic nerve palsy / paresis * Vascular access complications * Heart block * Gastric motility / pyloric spasm disorders Through 30 Days: * Cardiac tamponade / perforation * Pericarditis Through 360 Days Post-Procedure: * PV stenosis * Atrio-esophageal fistula Phase 2 Through 7 Days: * Myocardial infarction * Stroke * Transient
Interventions
- DEVICE Phase 1: FARAPULSE Ablation System
- DEVICE Phase 2: FARAPULSE Ablation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 669 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2025-02-11 |
| Phase | NA |
What the finished NCT05443594 record still lists
NCT05443594 is an interventional study that assigns participants to a tested intervention. The registered 669 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Phase 1: FARAPULSE Ablation System is the first listed.
NCT05443594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05443594 about?
NCT05443594 is a clinical study titled "A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation". The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation (PersAF).
What is the current status of trial NCT05443594?
This trial is currently completed. It is a NA study. The enrollment target is 669 participants. The study started on 2023-02-28. Estimated completion is 2025-02-11.
What interventions are being tested in trial NCT05443594?
The interventions under investigation include: Phase 1: FARAPULSE Ablation System (DEVICE), Phase 2: FARAPULSE Ablation System (DEVICE).
Who is sponsoring clinical trial NCT05443594?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05443594's enrollment target sits among peer trials
669 154th of 2000 higher than 1,847 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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