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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Georgia
Israeli-Georgian Medical Research Clinic Helsicore
COMPLETED
Tbilisi
Tbilisi Heart and Vascular Clinic
COMPLETED
Tbilisi
Lithuania
Vilnius university hospital Santaros Klinikos
RECRUITING
Vilnius
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Uzbekistan
Ezgu Niyat
RECRUITING
Tashkent
Contact Information
Primary
Boaz Schwarz
boaz@endomaticmed.com
+972 (0)544595839
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2027-05
Participants
Target number of participants: 15
Treatments
Experimental: Implantable device
Endomatic SEPIOLA System
Related Therapeutic Areas
Sponsors
Leads: Endomatic Ltd.

This content was sourced from clinicaltrials.gov