Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf. Dr. med. Ingo Eitel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Ability to give informed consent
Documented NVAF (paroxysmal, persistent, or permanent)
CHA2DS2VASc risk score ≥2
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Left Atrial Appendage closure
Other interventionPercutaneous closure of the LAA
Treatment groups
430 Participants
are divided into 2 treatment groupsGroup A: Experimental interventionExperimental treatment 1 intervention
Group B: Control interventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
"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)
Time frame
Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof. Dr. med. Ingo Eitel
Lead sponsor
University of Luebeck
Sponsor institution
Source ClinicalTrials.gov