Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT07227532

A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

Led by Biosense Webster, Inc. · Updated on 2026-05-11

276

Participants Needed

12

Research Sites

271 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic paroxysmal atrial fibrillation who are candidates for catheter ablation
  • Refractory or contraindicated to at least one Class I/III antiarrhythmic drug
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Not Eligible

You will not qualify if you...

  • Previously diagnosed with persistent or long-standing persistent atrial fibrillation (more than 7 days in duration)
  • Previous surgical or catheter ablation for atrial fibrillation
  • Significant congenital anomaly or medical problem contraindicating catheter ablation
  • Current enrollment in another investigational study evaluating a device or drug
  • Life expectancy less than 12 months
  • Any contraindications as defined in the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States, 85018

Actively Recruiting

2

Tucson Medical Center Pima Heart and Vascular

Tucson, Arizona, United States, 85704

Actively Recruiting

3

OC Memorial

Fountain Valley, California, United States, 92708

Actively Recruiting

4

Community Memorial Hospital

Ventura, California, United States, 93003

Actively Recruiting

5

Orlando Health Heart and Vascular Institute

Orlando, Florida, United States, 32806

Actively Recruiting

6

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States, 66211

Actively Recruiting

7

Trinity Health

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

8

Albert Einstein College Of Medicine - Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

9

Springfield Medical Center

Springfield, Ohio, United States, 45504

Actively Recruiting

10

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States, 78705

Actively Recruiting

11

Winchester Medical Center

Winchester, Virginia, United States, 22601

Actively Recruiting

12

Mercy Hospital

Janesville, Wisconsin, United States, 53548

Actively Recruiting

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Research Team

E

Emily Purcell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System | DecenTrialz