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RECRUITING
NCT06401616
PHASE4

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

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1220

Start Date

2024-05-21

Completion Date

2028-03

Last Updated

2024-05-23

Healthy Volunteers

No

Interventions

DRUG

OAC will be discontinued for the duration of the trial

Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Locations (6)

Rigshospitalet

Copenhagen, Capital Region, Denmark

Gentofte Hospital

Gentofte Municipality, Capital Region, Denmark

Regionshospital Gødstrup

Herning, Central Jutland, Denmark

Aalborg university hospital

Aalborg, North Denmark, Denmark

Århus Universitetshospital

Aarhus, Region Midt, Denmark

Odense University Hospital

Odense, Region Syddanmark, Denmark