Skip to main content
Clinical Trials/NCT04613401
NCT04613401
Unknown
N/A

Association of Telemonitoring With Hospitalization Rates and Quality of Life in Patients With End-stage Heart Failure and Implanted Left Ventricular Cardiac Assist Devices

University Hospital, Essen1 site in 1 country50 target enrollmentJuly 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University Hospital, Essen
Enrollment
50
Locations
1
Primary Endpoint
Number of days spent in the hospital due to VAD-associated complications
Last Updated
5 years ago

Overview

Brief Summary

The current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (LVAD) has an influence on LVAD-associated complications, hospitalization rates and quality of life. This is a prospective observational study. Patients with terminal heart failure and an implanted LVAD, where the indication for telemonitoring has already been stated by the attending physician are included in the study. Written informed consent is obtained from all patients. The telemedical monitoring is carried out by the West German Center for Applied Telemedicine (WZAT) and includes a standardized telephone interview every 3 days. In addition, all patients are equipped with an INR measuring device, a body scale and a clinical thermometer by WZAT. The data is documented in an electronic case file (medPower®). In the event of abnormalities, the West German Heart and Vascular Center (WHGZ) is contacted, and all necessary measures are initiated.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
December 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Essen
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age\> 18 years
  • Indication for telemedicine
  • Permanently implanted left ventricular assist device (VAD)

Exclusion Criteria

  • no possibility of telephone contact
  • patient does not speak german
  • incompliance
  • rejection or inability to give consent

Outcomes

Primary Outcomes

Number of days spent in the hospital due to VAD-associated complications

Time Frame: 6 months

VAD-associated complications are defined as * bleeding with the need for a transfusion * infection with the need for an antibiotic therapy * thrombosis with the need for a lysis therapy

Secondary Outcomes

  • Change in quality of life from baseline(6 months)
  • Change in depression from baseline(6 months)
  • Number of VAD-associated complications(6 months)

Study Sites (1)

Loading locations...

Similar Trials