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A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

RecruitingNAAges 22 Years - anyAllBiosense Webster, Inc.
NCT07227532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
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Where

23 sites
Phoenix Cardiovascular Research Group
Phoenix, United States
Tucson Medical Center Pima Heart and Vascular
Tucson, United States
OC Memorial
Fountain Valley, United States
Community Memorial Hospital
Ventura, United States
Aurora Denver Cardiology Associates
Aurora, United States
Mayo Clinic in Florida
Jacksonville, United States
HCA Florida Mercy Hospital
Miami, United States
Orlando Health Heart and Vascular Institute
Orlando, United States

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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