Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery

Launched by UNIVERSITY OF TURKU · Dec 16, 2014

Keywords

ClinConnect Summary

The LAA-CLOSURE trial is studying whether closing a small pouch in the heart called the left atrial appendage (LAA) can help prevent blood clots in patients who are having aortic valve replacement surgery. This trial is for adults aged 18 and older who have a certain risk score indicating they might benefit from the procedure but do not need long-term blood thinner medications at the time of enrollment. The study will include about 1,040 participants, who will be divided into two groups: one will receive standard care along with the LAA closure, while the other will receive only the standard care.

If you or a family member are considering participating, you should be aware that you must be undergoing aortic valve replacement surgery and be willing to follow up with the study requirements. This trial is currently recruiting participants, and it spans five years, with additional follow-up for another ten years. It’s important to note that certain conditions, like having chronic atrial fibrillation or needing long-term blood thinners, would make you ineligible for this study. If you have questions about your eligibility or the study itself, it's best to speak with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients undergoing aortic valve replacement (+/- coronary bypass AND/OR mitral valve surgery) according to clinical indications (ESC guidelines for the management of valvular heart disease)
• • 2. Age ≥18 years
• • 3. No indication for long term anticoagulation at the time of enrollment.
• • 4. Patients with CHADS-VASC score ≥2
• • 5. Patient is willing to comply with specified follow-up evaluations
• • 6. 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
• • Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.