NCT06099106Recruiting
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
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 19 Oct 2023
- Start date
- 1 May 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- Endomatic Ltd.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06099106
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 May 2023 to the primary completion date, Jun 2026
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject who requires anticoagulation for a condition other than AF.
- Complex congenital heart disease.
- Any cardiac surgery in the past
Lab values
- LVEF \< 35%.
Other
- NYHA classification IV.
- 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.
- intracardiac thrombus
- moderate or severe mitral valve stenosis
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Israeli Georgian Medical Research Clinic Helsicore Coordinator of this site? Confirm its status | Tbilisi | Georgia | Completed |
| Tbilisi Heart and Vascular Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Completed |
| Vilnius University Hospital Santaros Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| Ezgu Niyat Coordinator of this site? Confirm its status | Tashkent | Uzbekistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.