Surgical closure of the left atrial appendage during aortic valve replacement

A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery

This study is testing if closing a small part of the heart called the left atrial appendage during aortic valve replacement can help patients with a higher risk of blood clots feel safer and healthier.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1040 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Turku (other)
• Locations: 4 sites (Helsinki and 3 other locations)
• Trial ID: NCT02321137 on ClinicalTrials.gov

What this trial studies

The LAA-CLOSURE trial evaluates the safety and efficacy of surgically closing the left atrial appendage (LAA) in patients undergoing aortic valve replacement who have a CHA2DS2-VASC score of 2 or higher but do not require anticoagulation. This international multicenter trial will randomly assign 1040 participants to receive either standard therapy with LAA closure or standard therapy alone. The study aims to provide robust evidence regarding the potential benefits of LAA closure in reducing thromboembolic events in this patient population over a five-year period, with additional follow-up extending to ten years.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older undergoing aortic valve replacement with a CHA2DS2-VASC score of 2 or more and no indication for long-term anticoagulation.

Not a fit: Patients with chronic atrial fibrillation or those requiring long-term anticoagulation therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of thromboembolic events in patients undergoing aortic valve replacement.

How similar studies have performed: While previous studies have suggested potential benefits of LAA closure, this trial is among the first large-scale randomized studies specifically addressing this intervention in the context of aortic valve replacement.

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.

Where this trial is running

Helsinki and 3 other locations

• Helsinki University Hospital — Helsinki, Finland (NOT_YET_RECRUITING)
• Kuopio University Hospital — Kuopio, Finland (RECRUITING)
• Turku University Hospital — Turku, Finland (RECRUITING)
• St Antonius Hospital — Utrecht, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Tuomas Kiviniemi, MD, PhD — Turku University Hospital, Turku, Finland
• Study coordinator: Tuija Vasankari, RN

Conditions: Aortic Stenosis