NCT07227532 A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
| NCT ID | NCT07227532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosense Webster, Inc. |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 276 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 276 participants in total. It began in 2025-10-21 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 symptomatic paroxysmal atrial fibrillation (PAF).
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
Contact & Investigator
Biosense Webster, Inc. Clinical Trial
STUDY DIRECTOR
Biosense Webster, Inc.
Frequently Asked Questions
Who can join the NCT07227532 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07227532 currently recruiting?
Yes, NCT07227532 is actively recruiting participants. Contact the research team at EPurcel1@its.jnj.com for enrollment information.
Where is the NCT07227532 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Fountain Valley, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT07227532 clinical trial?
NCT07227532 is sponsored by Biosense Webster, Inc.. The principal investigator is Biosense Webster, Inc. Clinical Trial at Biosense Webster, Inc.. The trial plans to enroll 276 participants.
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