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

NCT05204212 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2024-05-13

No results posted yet for this study

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

Interventions

OTHER

Left Atrial Appendage closure

Percutaneous closure of the LAA

Sponsors & Collaborators

  • Prof. Dr. med. Ingo Eitel

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2026-01-14
Completion
2028-01-14

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204212 on ClinicalTrials.gov