Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEndomatic Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subject who requires anticoagulation for a condition other than AF.
NYHA classification IV.
Complex congenital heart disease.
Presence of circumflex coronary artery stent.
Trial design
Design model
Single group
Treatments tested in this trial
SEPIOLA System
DeviceImplantation of the SEPIOLA device into the left atrial appendage.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Implantable deviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SEPIOLA System Safety
Device and Investigational Procedure Related Serious Adverse Events (SAE)
Time frame
7 days, 45 days and 6 months post procedureSecondary outcomes
1
Device success
Confirmation of functional LAA closure
Time frame
45 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov