CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF)

April 1, 2022 updated by: Abbott Medical Devices
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Coburg, Bavaria, Germany, 96450
        • Klinukum Coburg
      • Würzburg, Bavaria, Germany, 97080
        • Universitätsklinikum Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
  • ≥ 18 years of age
  • Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
  • Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
  • Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
  • Written informed consent obtained from subject

Exclusion Criteria:

  • Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
  • Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CardioMEMS HF System
Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.
Device: CardioMEMS HF System
Pulmonary Artery Pressure Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Device/System Related Complications
Time Frame: one year
This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.
one year
Freedom From Pressure Sensor Failure
Time Frame: one year
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
one year
Percent of Successful Pulmonary Artery Pressure Data Transmissions
Time Frame: one year
Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Hospitalization (HFH) Rate
Time Frame: one year
Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Christiane Angermann, Prof. Dr., Deutsches Zentrum für Herzinsuffizienz Würzburg
  • Principal Investigator: Michael Boehm, Prof. Dr., University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

February 20, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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