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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06099106
Other study ID # DMS-6283
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date May 2025

Study information

Verified date October 2023
Source Endomatic Ltd.
Contact Boaz Schwarz
Phone +972 (0)544595839
Email boaz@endomaticmed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date May 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.

Locations

Country Name City State
Georgia Israeli-Georgian Medical Research Clinic Helsicore Tbilisi
Georgia Tbilisi Heart and Vascular Clinic Tbilisi

Sponsors (1)

Lead Sponsor Collaborator
Endomatic Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type Measure Description Time frame Safety issue
Primary SEPIOLA System Safety Device and Investigational Procedure Related Serious Adverse Events (SAE) 7 days, 45 days and 6 months post procedure
Secondary Device success Confirmation of functional LAA closure 45 days
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