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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099106
• Other study ID #: DMS-6283
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Endomatic Ltd.
• Contact: Boaz Schwarz
• Phone: +972 (0)544595839
• Email: boaz[@]endomaticmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• SEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Endomatic Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SEPIOLA System Safety	Device and Investigational Procedure Related Serious Adverse Events (SAE)	7 days, 45 days and 6 months post procedure
Secondary	Device success	Confirmation of functional LAA closure	45 days