Actively Recruiting
Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Led by Biosense Webster, Inc. · Updated on 2026-06-05
276
Participants Needed
19
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system used for pulmonary vein isolation (PVI) in people with symptomatic paroxysmal atrial fibrillation (PAF). This trial aims to evaluate how well this device manages treatment for this heart rhythm condition over an extended period. Participants who have symptomatic paroxysmal atrial fibrillation and are undergoing electrophysiology mapping and pulsed field ablation (PFA) will receive pulmonary vein ablation using the VARIPULSE catheter paired with a TRUPULSE generator. This treatment is designed to manage their atrial fibrillation symptoms by targeting specific areas of the heart. During the study, participants will be monitored for early onset primary adverse events within seven days after the ablation procedure. Researchers will also track freedom from both symptomatic and asymptomatic atrial tachyarrhythmia episodes from day 61 up to nearly three years after the procedure. Participants must comply with all pre-treatment, post-treatment, and follow-up testing and requirements throughout the study, which extends over a long-term period.
CONDITIONS
Brief 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 (AF) and considered a candidate for catheter ablation for AF
- Refractory or contraindicated to at least one Class I or III antiarrhythmic drug
- Willing and able to provide consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You will not qualify if you...
- Diagnosed with persistent or long-standing persistent AF lasting more than 7 days
- Previous surgical or catheter ablation for AF
- Significant congenital anomaly or medical problem contraindicating catheter ablation
- Currently enrolled in another investigational study involving a device or drug
- Life expectancy less than 12 months
- Any other contraindications as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo electrophysiology mapping and pulsed field ablation (PFA) for management of symptomatic paroxysmal atrial fibrillation using the VARIPULSE Catheter with a TRUPULSE Generator.
1 procedure visit (in-person)
Duration - Up to approximately 3 years
Participants are monitored for safety and effectiveness after the ablation procedure.
Multiple follow-up visits between Day 7 and Day 1095 post-procedure
Trial Site Locations
Total: 19 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
San Diego Cardiac Center
San Diego, California, United States, 92123
Withdrawn
5
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Withdrawn
6
Community Memorial Hospital
Ventura, California, United States, 93003
Actively Recruiting
7
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
Actively Recruiting
8
Colorado Heart and Vascular PC
Golden, Colorado, United States, 80401
Withdrawn
9
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States, 32806
Actively Recruiting
10
Deaconess Gateway Hospital
Newburgh, Indiana, United States, 47630
Withdrawn
11
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66211
Actively Recruiting
12
Trinity Health
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
13
Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
14
Springfield Medical Center
Springfield, Ohio, United States, 45504
Actively Recruiting
15
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
16
Baylor Scott and White Research Institute
Fort Worth, Texas, United States, 76104
Actively Recruiting
17
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
18
Winchester Medical Center
Winchester, Virginia, United States, 22601
Actively Recruiting
19
Mercy Hospital
Janesville, Wisconsin, United States, 53548
Actively Recruiting
Research Team
E
Emily Purcell
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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