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Early Versus Emergency Left Ventricular Assist Device Implantation in Patients Awaiting Cardiac Transplantation

NCT02387112 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-10-26

No results posted yet for this study

Summary

The aim of the study is to assess whether, in patients who are listed for cardiac transplantation in transplantable (T) status, early implantation of a left ventricular assist device is superior to the current therapeutic strategy of medical heart failure therapy and assist device implantation only after serious deterioration of the patient's condition.

Conditions

  • End Stage Heart Disease

Interventions

DEVICE

Early VAD implantation

Implantation of a left ventricular assist device

Sponsors & Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER

  • Helmholtz Zentrum München

    collaborator INDUSTRY

  • University Medicine Greifswald

    collaborator OTHER

  • University of Göttingen

    collaborator OTHER

  • German Heart Institute

    lead OTHER

Principal Investigators

  • Volkmar Falk, MD, PhD · German Heart Institute Berlin Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2024-03-31
Completion
2024-12-31

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 NCT02387112 on ClinicalTrials.gov