Evaluation of Longterm Outcome of New York Heart Associat... | NCT03020043

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 12, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2019

Last Update Posted Date

Sep 18, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Birgit Assmus, PD Dr., Prof. Dr. med., Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Birgit Assmus, MD	Contact	+49 69 6301	84690	birgit.assmus@kgu.de
Andreas M Zeiher, MD	Contact	+49 69 6301	5789	zeiher@em.uni-frankfurt.de

Overall Officials

Name	Affiliation	Role
Birgit Assmus, MD	Klinikum Goethe University Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Goethe University	Recruiting	Frankfurt am Main		60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29893475	Result	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.
27844194	Result