Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease (LAA-KIDNEY)

Prof. Dr. med. Ingo Eitel

Status: Enrolling

Conditions: Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

Treatments: Other: Left Atrial Appendage closure

Study type: Interventional

Funder types: Other

Identifiers

NCT05204212

21-392

Details and patient eligibility

About

In the proposed event driven trial, LAA closure devices will be compared in a 1:1 randomization to best medical care in AF patients at high risk of stroke and bleeding with ESKD. The trial will allow the use of the CE marked and clinically used LAA device Amplatzer Cardiac Plug and/or Amulet and all approved medical therapies in AF patients with ESKD including vitamin-K antagonists (VKA), NOACs as well as antiplatelet agents or no anticoagulation in excessive bleeding risk.

Full description

The purpose of the current study is to evaluate the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) and end-stage renal failure.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Ability to give informed consent
• Documented NVAF (paroxysmal, persistent, or permanent)
• CHA2DS2VASc risk score ≥2
• Chronic kidney disease KDOQI stage 5 (eGFR <15 ml/min/1.73m2) with or without hemodialysis

Exclusion criteria

• Absolute contraindication to aspirin and/or clopidogrel
• Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
• Present LAA thrombus
• Mobile aortic atheroma
• Age ≤18 years
• Patients presenting with pregnancy
• Patients without informed consent
• Participation in another trial
• Expected life expectancy <2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

Experimental intervention

Experimental group

Description:

Percutaneous closure of the LAA by use of the CE-mark approved LAA exclusion device Amplatzer Cardiac Plug or Amulet followed by dual antiplatelet therapy with aspirin 100mg od and clopidogrel 75 mg od for 3 months. In patients with excessive bleeding risk DAPT duration can be shortened according to the physicians' discretion to a minimum of 6 weeks. Oral anticoagulants are not prescribed in this group.

Treatment:

Other: Left Atrial Appendage closure

Control intervention

No Intervention group

Description:

No catheter-based LAA closure. Treatment with best medical care (warfarin or NOAC therapy or other best medical care if (N)OAC therapy is contraindicated).