Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: SEPIOLA System

• Registration Number: NCT06099106
• Lead Sponsor: Endomatic Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25
• Primary Completion: 2025-04
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantable device	SEPIOLA System	Endomatic SEPIOLA System

Primary Outcome Measures

Name	Time	Method
SEPIOLA System Safety	7 days, 45 days and 6 months post procedure	Device and Investigational Procedure Related Serious Adverse Events (SAE)

Secondary Outcome Measures

Name	Time	Method
Device success	45 days	Confirmation of functional LAA closure

Trial Locations

Locations (2)

Israeli-Georgian Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia