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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03020043
Date of registration:	11/01/2017
Prospective Registration:	No
Primary sponsor:	Johann Wolfgang Goethe University Hospital
Public title:	Evaluation of Longterm Outcome of New York Heart Association Class III Heart Failure Patients Receiving Telemonitoring Using a Pulmonary Artery Pressure Sensor System (CardioMEMS)
Scientific title:	CardioMEMS Registry of the Frankfurt Heart Failure Center
Date of first enrolment:	August 2016
Target sample size:	500
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03020043
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Germany

Contacts

Name:	Birgit Assmus, MD
Address:
Telephone:	+49 69 6301
Email:	birgit.assmus@kgu.de
Affiliation:

Name:	Birgit Assmus, MD
Address:
Telephone:
Email:
Affiliation:	Klinikum Goethe University Frankfurt

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Heart Failure

Intervention(s)

Primary Outcome(s)

morbidity measured as worsening heart failure requiring hospitalisation and / or increase in diuretic dose [Time Frame: 5 years]

Secondary Outcome(s)

Secondary ID(s)

FFM CardioMEMS Registry

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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