Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
Condition(s) studied
Investigational drug(s) / intervention(s)
Omega™LAA Occluder implantation: Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
Study summary
The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.
Eligibility
Primary outcome measure(s)
- LAA (Left Atrial Appendage) closure — According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place after the procedure - depending on local treatment standards).
The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler. - Device related complications — According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards).
Serious adverse events (SAE)
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Rigshospitalet, Kardiologisk klinik B 2011 | Copenhagen | Blegdamsvej 9 | |
| Aarhus University Hospital | Aarhus | Denmark | |
| CardioVasculäres Centrum, Seckbacher Landstrasse 65 | Frankfurt | Frankfurt | |
| Charité - University Medicine Berlin - Campus Benjamin Franklin | Berlin | Hindenburgdamm 30 | |
| Herzzentrum Leipzig | Leipzig | Strümpellstraße 39 | |
| Cardioangiologisches Centrum Bethanien | Frankfurt | Wilhelm-Epstein-Str. 4 | |
| Mater Private Network | Dublin | Ireland | |
| Università Campus Biomedico Roma | Rome | Via Álvaro Del Portillo, 200 | |
| Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario | Valladolid | Avda. Ramón Y Cajal 3 | |
| Hospital Clinico San Carlos | Madrid | Calle Del Prof Martín Lagos | |
| Complejo Hospitalario de Salamanca | Salamanca | Junta de Castilla Y LeónPaseo de San Vicente | |
| Hospital de la Santa Creu I Sant Pau | Barcelona | Sant Antoni Maria Clare | |
| University Hospitals Sussex NHS Foundation Trust Clinical Research Facility | Brighton | East Sussex |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04829929 on ClinicalTrials.gov ↗ ← All trials in Italy