Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)

CardioMEMS Registry of the Frankfurt Heart Failure Center

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03020043

Enrollment

500

Registered

2017-01-13

Start date

2016-08-31

Completion date

2025-12-31

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose	5 years	morbidity

Countries

Germany

Contacts

Primary ContactBirgit Assmus, MD

birgit.assmus@kgu.de+49 69 6301

Backup ContactAndreas M Zeiher, MD

zeiher@em.uni-frankfurt.de+49 69 6301

Outcome results