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

Launched by ENDOMATIC LTD. · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called the ENDOMATIC SEPIOLA, which aims to close a small part of the heart called the left atrial appendage (LAA) in patients with a condition known as non-valvular atrial fibrillation. People with this condition are at higher risk of having a stroke, and some cannot take blood-thinning medications for various reasons. The goal of the trial is to evaluate how safe and effective this device is for these patients.

To participate, individuals typically need to have a specific score indicating their stroke risk and should be looking for an alternative to long-term blood thinners. Eligible participants will go through a screening process and have their heart's structure assessed to ensure they are suitable for the procedure. After the procedure, patients will be monitored in the hospital and will have follow-up visits at 45 days, 6 months, and 12 months to check on their progress. This trial is currently recruiting participants aged 65 to 74, and it welcomes all genders.

Gender

ALL

Eligibility criteria

• 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