Actively Recruiting
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Led by Endomatic Ltd. · Updated on 2025-08-17
15
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Calculated CHA2DS2-VASc score of 2 or greater
- Non-eligible for or have a reason to seek a non-pharmacologic alternative to long-term oral anticoagulants
- Documented non-valvular atrial fibrillation
- Suitable for vascular or cardiac intervention procedure
- Suitable left atrial appendage anatomical measurements for the study device
You will not qualify if you...
- Requires anticoagulation for conditions other than atrial fibrillation
- New York Heart Association (NYHA) classification IV
- Complex congenital heart disease
- Presence of circumflex coronary artery stent
- Has a prosthetic heart valve in any position
- Has atrial septal defect closure or an ASD/PFO device
- Presence of intracardiac thrombus
- Any prior cardiac surgery
- Left ventricular ejection fraction (LVEF) less than 35%
- Moderate or severe mitral valve stenosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia, 0112
Completed
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
Completed
3
Vilnius university hospital Santaros Klinikos
Vilnius, Lithuania
Actively Recruiting
4
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Actively Recruiting
5
Ezgu Niyat
Tashkent, Uzbekistan
Actively Recruiting
Research Team
B
Boaz Schwarz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here