Actively Recruiting
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
Eligibility Criteria
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
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
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
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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