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.
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…
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