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Clinical Trials/NCT03020043
NCT03020043
Recruiting
Not Applicable

CardioMEMS Registry of the Frankfurt Heart Failure Center

Johann Wolfgang Goethe University Hospital2 sites in 1 country500 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
500
Locations
2
Primary Endpoint
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

Invasive hemodynamic monitoring in advanced heart failure patients is a relative new option. In order to investigate the impact of remote telemonitoring of pulmonary artery pressures on mortality and morbidity in a routine clinical setting in Germany, the investigators initiated this multicenbtric registry.

Detailed Description

All patients who receive invasive hemodynamic monitoring using a pulmonary artery pressure sensor (CardioMEMS device) are offered participation in the registry. Routine heart-failure parameters, lab values, medication and QoL as obtained on the regular outpatients visits in the department are entered into a registry-specific database. The investigators plan to asses the impact of telemonitoring on mortality, morbidity and QoL as well as on Guideline-recommended heart failure medication. In addition, it is planned to quantify the input in person time for telemonitoring.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2025
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Birgit Assmus, PD Dr.

Prof. Dr. med.

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

Inclusion Criteria

  • Implantation of CardioMEMS successful
  • Telemonitoring according to the SOP of the Frankfurt Heart Failure Center (Goethe University)

Exclusion Criteria

  • Unwillingness to participate in the registry

Outcomes

Primary Outcomes

morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose

Time Frame: 5 years

morbidity

Study Sites (2)

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