MedTrace Logo

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

NCT02321137 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2025-06-10

No results posted yet for this 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).

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Landspitali University Hospital

    collaborator OTHER

  • University of Turku

    lead OTHER

Principal Investigators

  • Tuomas Kiviniemi, MD, PhD · Turku University Hospital, Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2025-04-30
Completion
2029-12-31

Countries

  • Finland
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02321137 on ClinicalTrials.gov