Clinical Trial

Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy

Study acronym: COMPARE-LAAO
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 21, 2024 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusion (LAAO) may provide a non-inferior alternative for cardioembolic stroke protection in patients tolerant to OAC. However, RCT data for LAAO is lacking in patients with contra-indications to OAC using antiplatelet (APT) or no therapy as usual care. The hypothesis underlying this trial is to demonstrate that LAAO is superior to usual care for the prevention of stroke.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-12-18; most recent amendment 2024-06-19.
Status change: Recruiting → Active, Not Recruiting 2024-06-19
Status change: Not Yet Recruiting → Recruiting 2021-02-23
Status change: Withheld → Not Yet Recruiting 2020-12-30
Trial Details
NCT Number NCT04676880
Lead Sponsor R&D Cardiologie
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Atrial Fibrillation, Anticoagulants and Bleeding Disorders
Enrollment 609 participants
Start Date 2021-01-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-06-21