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

August 13, 2025 updated by: Endomatic Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0112
        • Completed
        • Israeli-Georgian Medical Research Clinic Helsicore
      • Tbilisi, Georgia, 0159
        • Completed
        • Tbilisi Heart And Vascular Clinic
  • Lithuania
      • Vilnius, Lithuania
  • Poland
  • Uzbekistan
      • Tashkent, Uzbekistan
        • Recruiting
        • Ezgu Niyat
        • Contact:
          • Askar Sabirov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantable device
Endomatic SEPIOLA System
Device: SEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEPIOLA System Safety
Time Frame: 7 days, 45 days and 6 months post procedure
Device and Investigational Procedure Related Serious Adverse Events (SAE)
7 days, 45 days and 6 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: 45 days
Confirmation of functional LAA closure
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endomatic Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMS-6283

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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