Tests a device that closes the heart's left atrial appendage in atrial fibrillation
Tests the SEPIOLA closure device in adults with atrial fibrillation who cannot take blood thinners.
Plain-language title generated from the registry record
Registry title: Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Key facts
- Where
- Tashkent, UzbekistanSee the site
Where in Uzbekistan
- Ezgu NiyatTashkent, UzbekistanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Endomatic Ltd.
- Trial code
- NCT06099106
- Record updated
- 17 August 2025
- Original description
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.Read full original descriptionShow less
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
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.
Inclusion: 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.
Exclusion: Subject who requires anticoagulation for a condition other than AF; Complex congenital heart disease; Any cardiac surgery in the past; LVEF < 35%; 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.