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

NCT03020043 | Unknown

• 1 other identifier: FFM CardioMEMS Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  morbidity

  5 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with New York Heart Association (NYHA) Class III with chronic heart failure (left and right ventricular heart failure, HFrEF, HFmrEF and HFpEF; +/- PH) , who had a hospitalisation for cardiac decompensation \< 12 months

You may qualify if:

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

You may not qualify if:

• Unwillingness to participate in the registry

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (2)

Klinikum Goethe University

Frankfurt am Main, 60590, Germany

RECRUITING

University Hospital Justus-Liebe University

Giessen, 35392, Germany

NOT YET RECRUITING

Related Publications (3)

• Herrmann E, Ecke A, Herrmann E, Eissing N, Fichtlscherer S, Zeiher AM, Assmus B. Daily non-invasive haemodynamic telemonitoring for efficacy evaluation of MitraClip(R) implantation in patients with advanced systolic heart failure. ESC Heart Fail. 2018 Oct;5(5):780-787. doi: 10.1002/ehf2.12303. Epub 2018 Jun 12.

  PMID: 29893475 RESULT

• 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 Dec;27(4):371-377. doi: 10.1007/s00399-016-0472-0. Epub 2016 Nov 14. German.

  PMID: 27844194 RESULT

• 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 Elektrophysiol. 2018 Dec;29(4):393-400. doi: 10.1007/s00399-018-0597-4. Epub 2018 Oct 10. German.

  PMID: 30306304 RESULT

Study Officials

• Birgit Assmus, MD

  Klinikum Goethe University Frankfurt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Birgit Assmus, MD

CONTACT

+49 69 6301; birgit.assmus@kgu.de

Andreas M Zeiher, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: August 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)