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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CardioMEMS HF System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinukum Coburg
  • Universitätsklinikum Würzburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CardioMEMS HF System

Arm Description

Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.

Outcomes

Primary Outcome Measures

Freedom From Device/System Related Complications
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.
Freedom From Pressure Sensor Failure
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Percent of Successful Pulmonary Artery Pressure Data Transmissions
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.

Secondary Outcome Measures

Heart Failure Hospitalization (HFH) Rate
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.

Full Information

First Posted
February 20, 2016
Last Updated
April 1, 2022
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02693691
Brief Title
CardioMEMS European Monitoring Study for Heart Failure
Acronym
MEMS-HF
Official Title
CardioMEMS European Monitoring Study for Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CardioMEMS HF System
Arm Type
Experimental
Arm Description
Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.
Intervention Type
Device
Intervention Name(s)
CardioMEMS HF System
Intervention Description
Pulmonary Artery Pressure Monitoring
Primary Outcome Measure Information:
Title
Freedom From Device/System Related Complications
Description
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.
Time Frame
one year
Title
Freedom From Pressure Sensor Failure
Description
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Time Frame
one year
Title
Percent of Successful Pulmonary Artery Pressure Data Transmissions
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Heart Failure Hospitalization (HFH) Rate
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane Angermann, Prof. Dr.
Organizational Affiliation
Deutsches Zentrum für Herzinsuffizienz Würzburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Boehm, Prof. Dr.
Organizational Affiliation
University Hospital, Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinukum Coburg
City
Coburg
State/Province
Bavaria
ZIP/Postal Code
96450
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34738340
Citation
Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4.
Results Reference
derived
PubMed Identifier
29777373
Citation
Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.
Results Reference
derived

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CardioMEMS European Monitoring Study for Heart Failure

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