NCT05204212

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Prof. Dr. med. Ingo Eitel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Left Atrial Appendage closure	Percutaneous closure of the LAA

Timeline

• Start date: 2022-03-28
• Primary completion: 2026-01-14
• Completion: 2028-01-14
• First posted: 2022-01-24
• Last updated: 2024-05-13

Locations

1 site across 1 country: Germany