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

NCT06099106 | Recruiting

• 1 other identifier: DMS-6283
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 5

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• SEPIOLA System Safety

  Device and Investigational Procedure Related Serious Adverse Events (SAE)

  7 days, 45 days and 6 months post procedure

Secondary Outcomes (1)

• Device success

  45 days

Study Arms (1)

Implantable device

EXPERIMENTAL

Endomatic SEPIOLA System

Device: SEPIOLA System

Interventions

SEPIOLA System DEVICE

Implantation of the SEPIOLA device into the left atrial appendage.

Implantable device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endomatic Ltd.: lead

Study Sites (5)

Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

COMPLETED

Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

COMPLETED

Vilnius university hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

RECRUITING

Ezgu Niyat

Tashkent, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Boaz Schwarz

CONTACT

+972 (0)544595839; boaz@endomaticmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

UZ (1); LI (1); GE (2); PL (1)