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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• SEPIOLA System Safety — 7 days, 45 days and 6 months post procedure
  Device and Investigational Procedure Related Serious Adverse Events (SAE)

Trial sites (5)

Other trials for the same condition