RecruitingPhase 4NCT06401616

Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)

Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)

Sponsor

Odense University Hospital

Enrollment

1,220 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Anticoagulant Adverse Reaction Left Atrial Appendage Absent

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether people with atrial fibrillation (AF) who have had their left atrial appendage (LAA) closed during heart surgery can safely stop taking blood thinners (anticoagulants). The LAA is a small pouch in the heart where clots typically form in AF, so closing it may eliminate the need for ongoing blood thinners. **You may be eligible if...** - You are 18 or older - You have a history of atrial fibrillation or atrial flutter - You have had cardiac surgery that included surgical closure of the left atrial appendage since 2010 - You are currently taking blood thinners (warfarin or a DOAC) **You may NOT be eligible if...** - You are not currently on blood thinners - You have a reason to stay on blood thinners unrelated to AF (such as a mechanical heart valve or prior blood clot in the lungs) - You have significant kidney impairment - You have an allergy to contrast dye - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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