NCT03463317

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

Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 912 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The individualized therapy with oral anticoagulants is considered to be an essential preventive therapy in patients with atrial fibrillation. The risk of stroke can be reduced by approximately 65%. However, long-term anticoagulation therapy also increases the risk of major bleeding. A significant proportion of patients at high risk of stroke do not tolerate long-term anticoagulation due to various relative or absolute contraindications. As demonstrated in previous studies with non-vitamin K antagonist anticoagulants (NOAK), 20-25% of patients were unable to tolerate long-term anticoagulation therapy. For this reason, additional therapeutic approaches for stroke prevention in patients with atrial fibrillation have been developed. A promising approach is catheter-based closure of the left atrial appendage, because more than 90% of cardiac thrombi in patients with non-valvular atrial fibrillation are detected in the left atrial appendage. Recent registry studies show that the safety of LAA occluder implantation is promising. However, further scientific studies are required, in order to explore more benefits of the underlying method and eligible patients for implantation. Study objectives: 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

Type	Name	Description
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

Timeline

• Start date: 2018-02-28
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2018-03-13
• Last updated: 2025-12-12

Locations

42 sites across 1 country: Germany