Left Atrial Appendage Closure for Irregular Heartbeat in Patients With Kidney Failure
Tests closing the left atrial appendage in adults with atrial fibrillation and end-stage kidney disease.
Plain-language title generated from the registry record
Registry title: Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Key facts
- Where
- Lübeck, GermanySee the site
Where in Germany
- Universität zu LübeckLübeck, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prof. Dr. med. Ingo Eitel
- Trial code
- NCT05204212
- Record updated
- 13 May 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis; Age ≤18 years; Expected life expectancy <2 years; Absolute contraindication to aspirin and/or clopidogrel; Present LAA thrombus; Mobile aortic atheroma; Patients presenting with pregnancy; Patients without informed consent; Participation in another trial.