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

Sponsor
Endomatic Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06099106
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
24
Anticipated Duration (Months)
7.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: SEPIOLA System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Implantable device

Endomatic SEPIOLA System

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

Outcome Measures

Primary Outcome Measures

  1. SEPIOLA System Safety [7 days, 45 days and 6 months post procedure]

    Device and Investigational Procedure Related Serious Adverse Events (SAE)

Secondary Outcome Measures

  1. Device success [45 days]

    Confirmation of functional LAA closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Israeli-Georgian Medical Research Clinic Helsicore Tbilisi Georgia 0112
2 Tbilisi Heart and Vascular Clinic Tbilisi Georgia 0159

Sponsors and Collaborators

  • Endomatic Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Endomatic Ltd.
ClinicalTrials.gov Identifier:
NCT06099106
Other Study ID Numbers:
  • DMS-6283
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Oct 25, 2023