NCT05204212Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 10 Jan 2022
- Start date
- 28 Mar 2022
- Primary completion date
- 14 Jan 2026
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- NCT number
- NCT05204212
What you commit to
- Study type: Interventional
- Planned participants: 430
- From 28 Mar 2022 to the primary completion date, 14 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Comorbidities other than AF requiring chronic (N)OAC therapy e.g. mechanical heart valve prosthesis
Age
- Age ≤18 years
- Expected life expectancy \<2 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universität zu Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.