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Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease (LAA-KIDNEY)

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ClinicalTrials.gov Identifier: NCT05204212
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : May 13, 2024
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ingo Eitel, University of Luebeck

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.

Condition or disease Intervention/treatment Phase
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent Other: Left Atrial Appendage closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : January 14, 2026
Estimated Study Completion Date : January 14, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental intervention
Percutaneous closure of the LAA by use of the CE-mark approved LAA exclusion device Amplatzer Cardiac Plug or Amulet followed by dual antiplatelet therapy with aspirin 100mg od and clopidogrel 75 mg od for 3 months. In patients with excessive bleeding risk DAPT duration can be shortened according to the physicians' discretion to a minimum of 6 weeks. Oral anticoagulants are not prescribed in this group.
Other: Left Atrial Appendage closure
Percutaneous closure of the LAA

No Intervention: Control intervention
No catheter-based LAA closure. Treatment with best medical care (warfarin or NOAC therapy or other best medical care if (N)OAC therapy is contraindicated).



Primary Outcome Measures :
  1. "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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05204212


Contacts
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Contact: Ingo Eitel, MD +49 451 500 44501 ingo.eitel@uksh.de
Contact: Thomas Stiermaier, MD +49 451 500 44501 thomas.stiermaier@uksh.de

Locations
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Germany
Universität zu Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Ingo Eitel, Prof. Dr. med.         
Contact: Thomas Stiermaier, Dr.med         
Sponsors and Collaborators
Prof. Dr. med. Ingo Eitel
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Responsible Party: Prof. Dr. med. Ingo Eitel, Director, University of Luebeck
ClinicalTrials.gov Identifier: NCT05204212    
Other Study ID Numbers: 21-392
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes