Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Conditions
Brief 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.
Interventions
OTHERLeft Atrial Appendage closure
Percutaneous closure of the LAA
Sponsors
Prof. Dr. med. Ingo Eitel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net clinical benefit | Day 0 | 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) |
Countries
Germany
Contacts
Primary ContactIngo Eitel, MD
Backup ContactThomas Stiermaier, MD
Outcome results
None listed