A randomized prospective multicenter trial for stroke prevention by surgical occlusion of the left atrial appendage in patients undergoing aortic valve bioprosthetic surgery

Recruiting

• Conditions: 10007521; Atrial fibrillation; heart rhythm disorder

• Registration Number: NL-OMON50187
• Lead Sponsor: Cardiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

- Patients undergoing aortic valve replacement (+/- coronary bypass AND/OR
mitral valve surgery)
- Age *18 years
- No indication for long term anticoagulation at the time of enrollment.
- Patients with CHA2DS2-VASC score *2
- Patient or legally authorized representative has been informed of the nature
of the study, agrees to its provisions and has been provided written informed
consent, approved by the appropriate Medical Ethics committee or Institutional
Review Board.

Exclusion Criteria

- Age < 18 years
- Expected survival < 1 year
- Chronic atrial fibrillation
- Indication for long term anticoagulation therapy before the index procedure
- Mechanical valve implantation previously or at the index procedure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- A composite of stroke, systemic embolism and cardiovascular mortality at 5<br /><br>years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Net adverse events (primary endpoint and major bleeding)<br /><br>- Cardiovascular mortality<br /><br>- Stroke<br /><br>- Hospitalization for decompensated heart failure<br /><br>- Major bleeding (BARC 3a, b, c or 5)<br /><br>- Any bleeding (BARC 1, 2 3a, b, c or 5)<br /><br>- Surgery related bleeding (BARC 4)</p><br>