Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06401616

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

Led by Odense University Hospital · Updated on 2024-05-23

1220

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the safety of stopping anticoagulant therapy in patients with atrial fibrillation who have had surgical closure of the left atrial appendage (LAA). This procedure is often done during cardiac surgery to reduce the risk of stroke and blood clots, which may allow patients to avoid ongoing blood thinners that increase bleeding risk. The ATLAAC trial is designed as a phase 4 randomized study to compare continued versus discontinued anticoagulation in this group. Participants will have undergone cardiac surgery with LAA closure verified by a cardiac CT scan. Those with successful closure are randomly assigned to either stop taking oral anticoagulants (such as warfarin or direct oral anticoagulants) or to continue them for the trial duration. This allows the trial to assess the risk of ischemic stroke, peripheral arterial embolism, and major bleeding events between the two approaches. During the approximately four-year follow-up, participants will be monitored for stroke severity, transient ischemic attacks, mortality rates, minor bleeding, and other cardiovascular events. Quality of life and patient satisfaction with treatment will also be evaluated at baseline and yearly intervals. The trial involves regular assessments to ensure safety and to measure key health outcomes related to anticoagulation status after LAA closure.

CONDITIONS

Brief 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 over 18 years
  • Previously had any type of cardiac surgery including surgical left atrial appendage closure from January 1, 2010, to 3 months before joining the study
  • Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter
  • Able to give informed consent
Not Eligible

You will not qualify if you...

  • Not currently taking oral anticoagulant medication (warfarin or direct oral anticoagulants)
  • Medical conditions requiring anticoagulants, such as mechanical heart valve or previous pulmonary embolism
  • Severe kidney impairment with estimated glomerular filtration rate below 30
  • Allergy to contrast dye used in imaging
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 4 years

Participants are randomized to either discontinue or continue oral anticoagulant therapy for the duration of the trial.

Regular visits according to study schedule over 4 years

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.

J

Julie Goller, M.D.

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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