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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06099106

Run by

Endomatic Ltd.

People needed

15

Starts

2023-05-01

Expected to finish

2027-05-01

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• calculated CHA2DS2-VASc score of 2 or greater.
• The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
• documented non-valvular atrial fibrillation
• Subject suitable for vascular/cardiac intervention procedure
• suitable LAA anatomical measurements for study device

You may not qualify if…

• Subject who requires anticoagulation for a condition other than AF.
• NYHA classification IV.
• Complex congenital heart disease.
• Presence of circumflex coronary artery stent.
• The subject has a prosthetic valve in any position.
• atrial septal defect closure or has an ASD/PFO device.
• presence of intracardiac thrombus.
• Any cardiac surgery in the past
• LVEF < 35%.
• intracardiac thrombus
• moderate or severe mitral valve stenosis

Where it is running

• Vilnius university hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland (enrolling)
• Ezgu Niyat — Tashkent, Uzbekistan (enrolling)
• Israeli-Georgian Medical Research Clinic Helsicore — Tbilisi, Georgia
• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia

Full record on ClinicalTrials.gov

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