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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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