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Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device

Atrial Fibrillation Clinical Trial

Official title:
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation

Clinical Trial Summary

The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy. Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06099106
Study type Interventional
Source Endomatic Ltd.
Contact Boaz Schwarz
Phone +972 (0)544595839
Email boaz@endomaticmed.com
Status Recruiting
Phase N/A
Start date May 1, 2023
Completion date May 2025
View Details
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