Status:
RECRUITING
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 s...
Eligibility Criteria
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
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT07227532
Start Date
October 21 2025
End Date
December 31 2030
Last Update
March 17 2026
Active Locations (7)
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1
OC Memorial
Fountain Valley, California, United States, 92708
2
Community Memorial Hospital
Ventura, California, United States, 93003
3
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States, 32806
4
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66211