RecruitingNot ApplicableNCT06099106

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

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

Sponsor

Endomatic Ltd.

Enrollment

15 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and performance of a new device called ENDOMATIC SEPIOLA, which is designed to close off a small pouch in the heart called the left atrial appendage (LAA). Closing this pouch can reduce the risk of stroke in people with an irregular heartbeat (atrial fibrillation) who cannot safely take blood thinners long-term. **You may be eligible if...** - You have been diagnosed with non-valvular atrial fibrillation (an irregular heartbeat not caused by a heart valve problem) - You have a stroke risk score (CHA2DS2-VASc) of 2 or more - You are not a good candidate for long-term blood thinners, or there is a valid reason to seek a non-medication alternative - The size and shape of your LAA is suitable for the device **You may NOT be eligible if...** - You need blood thinners for a reason other than atrial fibrillation - You have severe heart failure (NYHA Class IV) - You have a complex congenital heart defect - You have had prior heart surgery or another heart device implanted (such as a valve replacement or ASD closure device) - You have a blood clot inside your heart - Your heart pumping function is very low (ejection fraction under 35%) - You have moderate or severe mitral valve narrowing (stenosis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.