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

RECRUITINGN/ASponsored by Biosense Webster, Inc.
Actively Recruiting
PhaseN/A
SponsorBiosense Webster, Inc.
Started2025-10-21
Est. completion2030-12-31
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →

NCT07227532

Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of the VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Eligibility

Age: 22 Years+Healthy volunteers accepted
Inclusion Criteria:

* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
* Refractory, intolerant, or contraindicated to Class I/III antiarrhythmic drugs (AAD)
* Willing and capable of providing consent
* Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

* Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration)
* Previous surgical or catheter ablation for AF
* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
* Current enrollment in an investigational study evaluating another device or drug
* Life expectancy less than 12 months
* Any contraindications as defined in the Protocol

Conditions2

Atrial FibrillationHeart Disease

Locations5 sites

California

1 site
Community Memorial Hospital
Ventura, California, 93003

Florida

1 site
Orlando Health Heart and Vascular Institute
Orlando, Florida, 32806

Texas

1 site
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705

Virginia

1 site
Winchester Medical Center
Winchester, Virginia, 22601

Wisconsin

1 site
Mercy Hospital
Janesville, Wisconsin, 53548

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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