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

Endomatic

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: SEPIOLA System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06099106

DMS-6283

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Implantable device

Experimental group

Description:

Endomatic SEPIOLA System

Treatment:

Device: SEPIOLA System