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

NCT ID: NCT03020043

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgit Assmus, PD Dr.

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgit Assmus, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum Goethe University Frankfurt

Locations

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Klinikum Goethe University

Frankfurt am Main, , Germany

Site Status RECRUITING

University Hospital Justus-Liebe University

Giessen, , Germany

Site Status NOT_YET_RECRUITING

Countries

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Germany

Central Contacts

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Birgit Assmus, MD

Role: CONTACT

+49 69 6301 ext. 84690

Andreas M Zeiher, MD

Role: CONTACT

+49 69 6301 ext. 5789

Facility Contacts

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Birgit Assmus, MD

Role: primary

+49 69 6301 ext. 84690

Ester Herrmann, MD

Role: backup

+49 69 6301 ext. 84690

Birgit Assmus, MD

Role: primary

+49 641 985 ext. 42637

Ardeschir Ghofrani, MD

Role: backup

+49 641 985 ext. 42421

References

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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.

Reference Type RESULT
PMID: 29893475 (View on PubMed)

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.

Reference Type RESULT
PMID: 27844194 (View on PubMed)

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.

Reference Type RESULT
PMID: 30306304 (View on PubMed)

Other Identifiers

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FFM CardioMEMS Registry

Identifier Type: -

Identifier Source: org_study_id

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