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Recruiting NCT06099106

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

No phase Interventional Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEPIOLA System.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Georgia, Lithuania, Poland, Uzbekistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation

Overview

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

  • Device SEPIOLA System
    Implantation of the SEPIOLA device into the left atrial appendage.

Primary outcome measures

  • SEPIOLA System Safety [Time frame: 7 days, 45 days and 6 months post procedure]
Secondary outcome measures (1)
  • Device success [Time frame: 45 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Georgia · 2 centers
  • Israeli-Georgian Medical Research Clinic Helsicore — Tbilisi
  • Tbilisi Heart and Vascular Clinic — Tbilisi
Lithuania · 1 center
  • Vilnius university hospital Santaros Klinikos — Vilnius
Poland · 1 center
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
Uzbekistan · 1 center
  • Ezgu Niyat — Tashkent

Identifiers

NCT: NCT06099106 · DMS-6283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗