Can patients with atrial fibrillation discontinue anticoagulant therapy after cardiac surgery: The ATLAAC trial

Phase 1

Recruiting

• Conditions: Atrial fibrillation; MedDRA version: 20.0Level: LLTClassification code: 10003660Term: Atrial fibrillation and flutter Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-502986-92-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

Age > 18 years, Previously undergone any type of cardiac surgical procedure including any type of surgical left atrial appendage closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the National Patient Register (NPR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 till April 1st 2023, Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record, Informed consent

Exclusion Criteria

Not receiving oral anticoagulant therapy (warfarin/DOAC), Patient specific conditions requiring OAC (e.g. mechanical valve, previous pulmonary embolism), Renal impairment (estimated glomerular filtration rate < 30), Allergy to contrast media, Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the risk of stroke, systemic embolisms and major bleeding events with and without anticoagulant therapy in patients with atrial fibrillation, who have previously undergone surgical left atrial appendage closure;Secondary Objective: To investigate the mortality risk with and without anticoagulant therapy in patients with atrial fibrillation, who have previously undergone surgical left atrial appendage closure, To investigate the success of surgical left atrial appendage closure in patients, who have previously undergone cardiac surgery including surgical LAA closure, To evaluate and compare the procedural success of different techniques of surgical left atrial appendage closure, To evaluate and compare health-related quality of life in relation to discontinuing anticoagulant therapy;Primary end point(s): Stroke, peripheral embolisms and major bleeding events (composite endpoint)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Ischemic stroke;Secondary end point(s):Hemorrhagic stroke;Secondary end point(s):Severity of stroke according to Scandinavian Stroke Scale;Secondary end point(s):Transient ischemic attack;Secondary end point(s):Systemic embolism;Secondary end point(s):All-cause stroke;Secondary end point(s):All-cause mortality;Secondary end point(s):Cardiovascular mortality;Secondary end point(s):All types of bleeding leading to hospital contact;Secondary end point(s):Blood transfusions;Secondary end point(s):Myocardial infarction;Secondary end point(s):Deep venous thrombosis;Secondary end point(s):Pulmonary embolism;Secondary end point(s):Length of the residual stump of the LAA;Secondary end point(s):Volume of the residual stump of the LAA;Secondary end point(s):Presence of contrast leakage across the closure line when relevant;Secondary end point(s):Presence of thrombi in the LAA or the left atrium;Secondary end point(s):Health-related quality of life scores