Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of 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
Other
Participants needed
175 (estimated)
Sponsor
Kardium Inc. · Industry
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About This Trial

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: 1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF. 1. Diagnosis must be confirmed within 12 months before enrollment. 2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or puls…
Contacts

Clinical Affairs

+1 (604) 248 8891

Clinical.Affairs@kardium.com

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