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Clinical Trials in the Netherlands / NCT02321137
Active, not recruiting Not applicable

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

NCT02321137 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University of Turku
Phase
Not applicable
Started
2014-11
Last updated
2025-06-10

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

Surgical closure of left atrial appendageNo closure of left atrial appendage

Surgical closure of left atrial appendage: aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. The operation as well as the pre and post-operative care will be performed according to local surgical policies.

No closure of left atrial appendage: aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Helsinki University Hospital Helsinki Finland
Kuopio University Hospital Kuopio Finland
Turku University Hospital Turku Finland
St Antonius Hospital Utrecht Netherlands

Other trials for the same condition

PERIGON Pivotal Trial Active, not recruiting
Post-Market Clinical Follow Up Study With Navitor Valve Recruiting
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial Active, not recruiting
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study Recruiting
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02321137 on ClinicalTrials.gov ↗ ← All trials in the Netherlands