Status:
RECRUITING
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Lead Sponsor:
Endomatic Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
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.
- 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
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06099106
Start Date
May 1 2023
End Date
May 1 2027
Last Update
August 17 2025
Active Locations (5)
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1
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia, 0112
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia, 0159
3
Vilnius university hospital Santaros Klinikos
Vilnius, Lithuania
4
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland