Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surg… (NCT06401616) | Clinical Trial Compass
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Denmark1,220 participantsStarted 2024-05-21
Plain-language summary
Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic embolism, which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding. A clinical trial to address the need for anticoagulation after LAA closure is needed.
The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure. Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation. The trial will assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding during the randomized intervention
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:
* Age \> 18 years
* Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project.
* Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record
* Informed consent
Exclusion Criteria:
* Not receiving OAC (warfarin/DOAC)
* Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism)
* Renal impairment (estimated glomerular filtration rate \< 30)
* Allergy to contrast media
* Pregnancy or breastfeeding
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
Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings
Timeframe: After 128 primary outcome events (approx 4 years)