NCT02321137Active, not recruiting
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery
A Randomized Prospective Multicenter Trial for Stroke Prevention by Surgical Occlusion of the Left Atrial Appendage in Patients Undergoing Aortic Bioprosthetic Surgery
Source: ClinicalTrials.gov · Last updated 10 Jun 2025
Brief summary (registry, in English)
The primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective, open-label international multicenter trial will enroll 1040 patients undergoing aortic valve replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical closure of LAA vs. standard therapy alone. The duration of the study is five years (plus additional 10 years).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1040 (estimated)
- First submitted
- 11 Dec 2014
- Start date
- Nov 2014
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- University of Turku
- Diseases
- Stroke
- NCT number
- NCT02321137
What you commit to
- Study type: Interventional
- Planned participants: 1040
- From Nov 2014 to the primary completion date, 30 Apr 2025
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for long term anticoagulation therapy before the index procedure
- Mechanical valve implantation previously or at the index procedure
Other illness
- Any significant medical condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study.
Age
- Age \< 18 years
Other
- Expected survival \< 1 year
- Chronic atrial fibrillation
Who the study is looking for
- 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)
- Age ≥18 years
- No indication for long term anticoagulation at the time of enrollment.
- Patients with CHADS-VASC score ≥2
- Patient is willing to comply with specified follow-up evaluations
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.