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NCT Number: NCT06099106

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israeli-Georgian Medical Research Clinic Helsicore, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SEPIOLA System

Device

Implantation of the SEPIOLA device into the left atrial appendage.

Primary outcomes

  1. SEPIOLA System Safety

    Time frame: 7 days, 45 days and 6 months post procedure

    Device and Investigational Procedure Related Serious Adverse Events (SAE)

Secondary outcomes

  1. Device success

    Time frame: 45 days

    Confirmation of functional LAA closure

Study contacts

Contact information is provided by the study sponsor or research team.

Boaz Schwarz

CONTACT

[email protected]

+972 (0)544595839

Sponsors and collaborators

Lead sponsor

Endomatic Ltd.

Industry

Registry information

Official study title

Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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