Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy (NCT04676880) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy
Netherlands609 participantsStarted 2021-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Documented non-valvular AF (paroxysmal or non-paroxysmal) and
✓. CHA2DS2-VASc score of 2 or more and
✓. Unsuitable for long-term use of oral anticoagulation as determined by the referring physician team as well as the multidisciplinary team in the study hospital and
✓. Suitable for dual APT for at least 3 months and single APT from 3 until at most 12 months and
✓. At least 18 years of age, and willing and able to provide informed consent and adhere to study rules and regulations and follow-up
Exclusion criteria
✕. Any invasive cardiac procedure within 30 days prior to randomization and 90 days after LAAO that would interfere with the study follow-up and medication
✕. Unsuitable LAA anatomy for closure or thrombus in the LAA at the time of procedure
✕. Contraindications or unfavourable conditions to perform cardiac catheterization or TEE
✕
What they're measuring
1
Time to first occurrence of ischemic or hemorrhagic or undetermined stroke.
Timeframe: Minimal follow up is 1 year, maximum follow up +/- 5 years
2
Time to first occurrence of the composite of stroke (ischemic or hemorrhagic or undetermined), TIA and systemic embolism.
Timeframe: Minimal follow up is 1 year, maximum follow up +/- 5 years
. Atrial septal malformations, atrial septal defect or a high-risk patient foramen ovale that may cause thrombo-embolic events
✕. Atrial septal defect repair or closure device or a patent foramen ovale repair or any other anatomical condition as this may preclude an LAAO procedure
✕. LVEF\<31% and/or heart failure NYHA 3-4
✕. Mitral valve regurgitation grade 3 or more
✕. Mitral stenosis as this makes AF by definition valvular in nature