Evaluating a device for closing the left atrial appendage in patients with atrial fibrillation
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
This study is testing a new device to see if it can safely close a part of the heart in patients with atrial fibrillation who are at risk for stroke and can’t take blood thinners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Endomatic Ltd. Industry-sponsored |
| Locations | 5 sites (Tbilisi and 4 other locations) |
| Trial ID | NCT06099106 on ClinicalTrials.gov |
What this trial studies
This study assesses 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 cannot take long-term anticoagulation therapy. Eligible patients will be screened based on specific criteria, including their CHA2DS2-VASc score and suitability for the procedure. Participants will undergo the closure procedure and will be monitored during the procedure and until hospital discharge, with follow-up assessments scheduled at 45 days, 6 months, and 12 months post-procedure.
Who should consider this trial
Good fit: Ideal candidates are patients with non-valvular atrial fibrillation, a CHA2DS2-VASc score of 2 or greater, and who are seeking a non-pharmacologic alternative to anticoagulation.
Not a fit: Patients who require anticoagulation for conditions other than atrial fibrillation or have severe cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a safer alternative for patients with atrial fibrillation who cannot use anticoagulants, potentially reducing their stroke risk.
How similar studies have performed: Other studies have explored LAA closure devices, showing promising results, but this specific device's performance is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tbilisi and 4 other locations
- Israeli-Georgian Medical Research Clinic Helsicore — Tbilisi, Georgia (Completed)
- Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (Completed)
- Vilnius university hospital Santaros Klinikos — Vilnius, Lithuania (Recruiting)
- Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland (Recruiting)
- Ezgu Niyat — Tashkent, Uzbekistan (Recruiting)
Study contacts
- Study coordinator: Boaz Schwarz
- Email: boaz@endomaticmed.com
- Phone: +972 (0)544595839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.