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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
Locations7 sites
View on ClinicalTrials.gov →

NCT07227532

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).

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 (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one 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

Locations7 sites

OC Memorial
Fountain Valley, California, 92708
Community Memorial Hospital
Ventura, California, 93003
Orlando Health Heart and Vascular Institute
Orlando, Florida, 32806
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705

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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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