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NCT07227532 · ClinicalTrials.gov registry record · NA
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
A NA study of Atrial Fibrillation, sponsored by Biosense Webster.
- Recruiting
- Registry status
- NA
- Development phase
- 276
- Enrollment target
- 7
- Study locations
NCT07227532: Recruiting NA study of Atrial Fibrillation, sponsored by Biosense Webster.
NCT07227532 is a NA study of Atrial Fibrillation that is actively recruiting participants, run by Biosense Webster. The registered enrollment target is 276 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227532, a NA study of Atrial Fibrillation, is actively recruiting participants, sponsored by Biosense Webster.
- RECRUITING
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Primary Outcome
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Conditions Studied
Interventions
- DEVICE Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Study Locations (7)
California
- OC Memorial - Fountain Valley
- Community Memorial Hospital - Ventura
Florida
- Orlando Health Heart and Vascular Institute - Orlando
Kansas
- The Kansas City Heart Rhythm Institute - Overland Park
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
Virginia
- Winchester Medical Center - Winchester
Wisconsin
- Mercy Hospital - Janesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2030-12-31 |
| Phase | NA |
What NCT07227532 shows while recruiting
NCT07227532 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator is the first listed.
NCT07227532 lists 7 locations in 6 states (California, Florida, Kansas).
Frequently Asked Questions
What is clinical trial NCT07227532 about?
NCT07227532 is a clinical study titled "A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System". The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
What is the current status of trial NCT07227532?
This trial is currently recruiting. It is a NA study. The enrollment target is 276 participants. The study started on 2025-10-21. Estimated completion is 2030-12-31.
What conditions does trial NCT07227532 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT07227532?
The interventions under investigation include: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator (DEVICE).
Who is sponsoring clinical trial NCT07227532?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227532 being conducted?
This trial has 7 study locations across California, Florida, Kansas, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07227532's enrollment target sits among peer trials
276 84th of 202 higher than 118 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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