Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
Recruiting
N/A
Interventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Medtronic Cardiac Ablation Solutions · Industry
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About This Trial
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Symptomatic paroxysmal or persistent atrial fibrillation (PAF) documented by:
* A physician's note indicating recurrent AF
* At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
2. Failure or intolerance of at least one Clas…
Contacts