Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation Compared to Medical Therapy

Summary

The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a \[non-vitamin K\] oral anticoagulant \[(N)OAC\] when eligible).

Conditions

• Atrial Fibrillation

Interventions

DEVICE

CE-mark approved LAA closure devices

LAA closure with post procedure treatment

DRUG

Acetylsalicylic acid

post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group

DRUG

Clopidogrel

post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group

DRUG

Dabigatran

Patients allocated to the best medical care group receive either NOAC therapy or VKA

DRUG

Rivaroxaban

Patients allocated to the best medical care group receive either NOAC therapy or VKA

DRUG

Apixaban

Patients allocated to the best medical care group receive either NOAC therapy or VKA

DRUG

Edoxaban

Patients allocated to the best medical care group receive either NOAC therapy or VKA

DRUG

Phenprocoumon

Patients allocated to the best medical care group receive either NOAC therapy or VKA

DRUG

Warfarin

Patients allocated to the best medical care group receive either NOAC therapy or VKA

Sponsors & Collaborators

• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

  collaborator OTHER

• Atrial Fibrillation Network

  collaborator OTHER

• Stiftung Institut fuer Herzinfarktforschung

  collaborator OTHER

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Ulf Landmesser, MD · Charite University, Berlin, Germany

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-28

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• Germany

Study Locations