Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
NCT ID: NCT06099106
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2023-05-01
2027-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implantable device
Endomatic SEPIOLA System
SEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.
Interventions
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SEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Endomatic Ltd.
INDUSTRY
Responsible Party
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Locations
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Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
Vilnius university hospital Santaros Klinikos
Vilnius, , Lithuania
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Ezgu Niyat
Tashkent, , Uzbekistan
Countries
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Central Contacts
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Facility Contacts
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Askar Sabirov, MD
Role: primary
Other Identifiers
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DMS-6283
Identifier Type: -
Identifier Source: org_study_id
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