Back to resultsLeft Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease (LAA-KIDNEY)
Primary Purpose
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Left Atrial Appendage closure
Sponsored by
About this trial
This is an interventional treatment trial for Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
Eligibility 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
Sites / Locations
- Universität zu LübeckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental intervention
Control intervention
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
"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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05204212
First Posted
January 10, 2022
Last Updated
May 17, 2022
Sponsor
Prof. Dr. med. Ingo Eitel
1. Study Identification
Unique Protocol Identification Number
NCT05204212
Brief Title
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
Acronym
LAA-KIDNEY
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
January 14, 2024 (Anticipated)
Study Completion Date
January 14, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. med. Ingo Eitel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Left Atrial Appendage closure
Intervention Description
Percutaneous closure of the LAA
Primary Outcome Measure Information:
Title
"Net clinical benefit"
Description
"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 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingo Eitel, MD
Phone
+49 451 500 44501
Email
ingo.eitel@uksh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Stiermaier, MD
Phone
+49 451 500 44501
Email
thomas.stiermaier@uksh.de
Facility Information:
Facility Name
Universität zu Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr. med.
First Name & Middle Initial & Last Name & Degree
Thomas Stiermaier, Dr.med
12. IPD Sharing Statement
Learn more about this trial
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
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