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

NCT05204212 | Recruiting

• 1 other identifier: 21-392
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation (NVAF): Paroxysmal, Persistent, Permanent

Outcome Measures

Primary Outcomes (1)

• "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)

  Day 0

Study Arms (2)

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.

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).

Interventions

Left Atrial Appendage closure OTHER

Percutaneous closure of the LAA

Experimental intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Ingo Eitel: lead

Study Sites (1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Ingo Eitel, MD

CONTACT

+49 451 500 44501; ingo.eitel@uksh.de

Thomas Stiermaier, MD

CONTACT

+49 451 500 44501; thomas.stiermaier@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 28, 2022
• Primary Completion: January 14, 2026
• Study Completion (Estimated): January 14, 2028
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

DE (1)