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

Chronic Heart Failure Clinical Trial

Official title:

CardioMEMS Registry of the Frankfurt Heart Failure Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03020043
• Other study ID #: FFM CardioMEMS Registry
• Status: Recruiting
• Start date: August 2016
• Est. completion date: December 2025

Study information

• Verified date: September 2019
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Birgit Assmus, MD
• Phone: +49 69 6301
• Email: birgit.assmus[@]kgu.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Germany	Klinikum Goethe University	Frankfurt am Main
Germany	University Hospital Justus-Liebe University	Gießen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Herrmann E, Ecke A, Fichtlscherer S, Zeiher AM, Assmus B. [Pulmonary artery pressure sensor for ambulatory assessment of ventricular filling pressure in advanced heart failure : What should be considered for the follow-up care?]. Herzschrittmacherther Ele — View Citation

Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip® implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5 — View Citation

Herrmann E, Fichtlscherer S, Hohnloser SH, Zeiher AM, Aßmus B. [Implantable sensors for outpatient assessment of ventricular filling pressure in advanced heart failure : Which telemonitoring design is optimal?]. Herzschrittmacherther Elektrophysiol. 2016 — View Citation

Outcome

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