Atrial Fibrillation
Conditions
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.
Interventions
DEVICESEPIOLA System
Implantation of the SEPIOLA device into the left atrial appendage.
Sponsors
Endomatic Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SEPIOLA System Safety | 7 days, 45 days and 6 months post procedure | Device and Investigational Procedure Related Serious Adverse Events (SAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | 45 days | Confirmation of functional LAA closure |
Countries
Georgia, Lithuania, Poland, Uzbekistan
Contacts
Primary ContactBoaz Schwarz
Outcome results
None listed