Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, PermanentLAA-KIDNEYNCT05204212
Left Atrial Appendage Closure in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic KIDNEY Disease
A study testing Left Atrial Appendage closure in people with Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent
- What is being tested?
- Left Atrial Appendage closure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteGermany
- Study dates
- 28 Mar 2022to 14 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients without informed consent
- Participation in another trial
- Expected life expectancy <2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universität zu Lübeck
Lübeck, Schleswig-Holstein, 23538
Ingo Eitel, Prof. Dr. med.
Thomas Stiermaier, Dr.med
About this study
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
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.
Read the 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.
- Being tested
- Left Atrial Appendage closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage closureOther
Percutaneous closure of the LAA
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | 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. Receives: Other: Left Atrial Appendage closure |
| Control intervention | No 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start28 Mar 2022
- Primary completion14 Jan 2026 (estimated)
- Study completion14 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, PermanentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204212
- Sponsor's protocol ID
- 21-392
- Acronym
- LAA-KIDNEY
- Status last verified
- May 2024
- First submitted
- 10 Jan 2022
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saraei R, Heine GH, Osmancik P, Schewel J, Sandri M, Landmesser U, Schwenger V, Latus J, Bekeredjian R, Chun J, Haeusler KG, Paitazoglou C, Sigusch H, Thiele H, Skurk C, Rychlik I, Schmidt B, Stiermaier T, Schneider S, Eitel I. Left atrial appendage closure in patients with non-valvular atrial fibrillation and end stage chronic KIDNEY disease: Rationale and design of the prospective randomized LAA-KIDNEY trial. Am Heart J. 2026 Oct;300:107474. doi: 10.1016/j.ahj.2026.107474. Epub 2026 May 8.
PubMed 42107551
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05204212
- Acronym / sponsor ID
- LAA-KIDNEY / 21-392
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 14 Jan 2026 (estimated)
- Study completion
- 14 Jan 2028 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Other: Left Atrial Appendage closurePercutaneous 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. |
| Control intervention | No 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage closurePercutaneous closure of the LAA | Other | Experimental intervention |
Primary outcome
"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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 42107551Saraei R, Heine GH, Osmancik P, Schewel J, Sandri M, Landmesser U, Schwenger V, Latus J, Bekeredjian R, Chun J, Haeusler KG, Paitazoglou C, Sigusch H, Thiele H, Skurk C, Rychlik I, Schmidt B, Stiermaier T, Schneider S, Eitel I. Left atrial appendage closure in patients with non-valvular atrial fibrillation and end stage chronic KIDNEY disease: Rationale and design of the prospective randomized LAA-KIDNEY trial. Am Heart J. 2026 Oct;300:107474. doi: 10.1016/j.ahj.2026.107474. Epub 2026 May 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage closure in people with Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingo Eitel, MD (+49 451 500 44501, ingo.eitel@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Net clinical benefit" (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.