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

NCT ID: NCT05204212

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2028-01-14

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Left Atrial Appendage closure

Intervention Type: OTHER

Percutaneous closure of the LAA

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Left Atrial Appendage closure

Percutaneous closure of the LAA

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. med. Ingo Eitel

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Ingo Eitel

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ingo Eitel, MD

Role: CONTACT

ingo.eitel@uksh.de

+49 451 500 44501

Thomas Stiermaier, MD

Role: CONTACT

thomas.stiermaier@uksh.de

+49 451 500 44501

Facility Contacts

Ingo Eitel, Prof. Dr. med.

Role: primary

Thomas Stiermaier, Dr.med

Role: backup

Other Identifiers

21-392

Identifier Type: -

Identifier Source: org_study_id