Status:
RECRUITING
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Lead Sponsor:
Prof. Dr. med. Ingo Eitel
Conditions:
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 14 2028
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT05204212
Start Date
March 28 2022
End Date
January 14 2028
Last Update
May 13 2024
Active Locations (1)
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1
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538