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

NCT06099106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-17

No results posted yet for this 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.

Conditions

Interventions

DEVICE

SEPIOLA System

Implantation of the SEPIOLA device into the left atrial appendage.

Sponsors & Collaborators

  • Endomatic Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2026-06-30
Completion
2027-05-31

Countries

  • Georgia
  • Lithuania
  • Poland
  • Uzbekistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099106 on ClinicalTrials.gov