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.
Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, Denmark
Aarhus University Hospital
Aarhus, Denmark
LAA (Left Atrial Appendage) closure
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.
Time frame: 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).
Device related complications
Serious adverse events (SAE)
Time frame: 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).
Procedure-related complications
All Serious Adverse Events
Time frame: Up to 7 days post-procedure
Device-related complications
All Serious Adverse Events including device thrombus
Time frame: 24 months
Major bleeding
Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed
Time frame: 24 months
Ischemic stroke
Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging
Time frame: 24 months
Systemic embolism
Confirmed by appropriate imaging
Time frame: 24 months
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CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, Frankfurt, Germany
Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, Germany
Herzzentrum Leipzig
Leipzig, Strümpellstraße 39, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Wilhelm-Epstein-Str. 4, Germany
Mater Private Network
Dublin, Ireland
Università Campus Biomedico Roma
Rome, Via Álvaro Del Portillo, 200, Italy
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Valladolid, Avda. Ramón Y Cajal 3, Spain
Hospital Clinico San Carlos
Madrid, Calle Del Prof Martín Lagos, Spain
...and 3 more locations
Pericardial effusion/tamponade
Confirmed by appropriate imaging
Time frame: 24 months
Technical success at implant
No device-related complications, occlusion of the left atrial appendage
Time frame: 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).
Procedural success
Technical success, no procedure-related complications except uncomplicated (minor) device embolization resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures
Time frame: 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).