Actively Recruiting
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Led by Odense University Hospital · Updated on 2024-05-23
1220
Participants Needed
6
Research Sites
197 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Previously had any type of cardiac surgery including surgical closure of the left atrial appendage from January 1, 2010 to 3 months before joining the study
- Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter
- Provided informed consent to participate
You will not qualify if you...
- Not currently receiving oral anticoagulant therapy (warfarin or direct oral anticoagulants)
- Medical conditions requiring anticoagulation such as mechanical heart valve or previous pulmonary embolism
- Severe kidney impairment with estimated glomerular filtration rate less than 30
- Allergy to contrast media used in imaging
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Rigshospitalet
Copenhagen, Capital Region, Denmark
Not Yet Recruiting
2
Gentofte Hospital
Gentofte Municipality, Capital Region, Denmark
Actively Recruiting
3
Regionshospital Gødstrup
Herning, Central Jutland, Denmark
Not Yet Recruiting
4
Aalborg university hospital
Aalborg, North Denmark, Denmark
Not Yet Recruiting
5
Århus Universitetshospital
Aarhus, Region Midt, Denmark
Actively Recruiting
6
Odense University Hospital
Odense, Region Syddanmark, Denmark
Actively Recruiting
Research Team
K
Kristina Gosvig, M.D.
CONTACT
J
Julie Goller, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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