Universität zu Lübeck
Lübeck, Schleswig-Holstein, 23538, Germany
Location status: Recruiting
Location contact
Ingo Eitel, Prof. Dr. med.
CONTACT
Thomas Stiermaier, Dr.med
CONTACT
Recruiting
NCT Number: NCT05204212
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Left Atrial Appendage closure
OtherPercutaneous closure of the LAA
Primary outcomes
-
"Net clinical benefit"
Time frame: 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)
Study contacts
Contact information is provided by the study sponsor or research team.
Ingo Eitel, MD
CONTACT
Thomas Stiermaier, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Prof. Dr. med. Ingo Eitel
Other
Registry information
Official study title
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
Acronym: LAA-KIDNEY
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- Jan 24, 2022
- Registry last updated
- May 13, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.