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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Randomized, Controlled, Unblinded, International, Multicentre, Parallel Two Group Trial of Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage

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

Intervention / Treatment
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* Other: Left Atrial Appendage closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental intervention<br>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. | Other: Left Atrial Appendage closure<br>* Percutaneous closure of the LAA<br>|
| No Intervention: Control intervention<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net clinical benefit | Net clinical benefit, defined as, time to first stroke (including ischemic or hemorrhagic strokes), systemic embolism, cardiovascular or unexplained death or major bleeding (BARC 3-5) | Day 0 |