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RecruitingNCT06099106Updated Aug 17, 2025

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

An interventional study of SEPIOLA System in Atrial Fibrillation, sponsored by Endomatic Ltd.. Recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Endomatic Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled May 2023, registered Oct 2023).
  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 15 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Endomatic Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Implantable device

    Endomatic SEPIOLA System

    Device: SEPIOLA System

Interventions

  • DeviceSEPIOLA System

    Implantation of the SEPIOLA device into the left atrial appendage.

06

What researchers measure

Primary outcomes

  1. SEPIOLA System Safety

    Device and Investigational Procedure Related Serious Adverse Events (SAE)

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

Secondary outcomes

  1. Device success

    Confirmation of functional LAA closure

    Time frame: 45 days

07

Study locations

3 of 5 sites recruiting
  • 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
    • Askar Sabirov, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06099106
Lead sponsor
Endomatic Ltd.
Responsible party
Sponsor
First posted
Oct 25, 2023
Start date
May 1, 2023
Primary completion
Jun 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 17, 2025

Study contacts

Boaz Schwarz
Contact
boaz@endomaticmed.com
+972 (0)544595839

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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