Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06401616

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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