Safety and Performance of the SpherePVI™ Catheter 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.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Medtronic Cardiac Ablation Solutions · Industry
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About This Trial

A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Symptomatic paroxysmal or persistent atrial fibrillation 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 Class I-IV…
Contacts

Sandra Jacobs

x

sandra.jacobs@medtronic.com

CONTACT