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Completed

NCT Number: NCT02693691

CardioMEMS European Monitoring Study for Heart Failure

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinukum Coburg, Coburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CardioMEMS HF System

Device

Pulmonary Artery Pressure Monitoring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: MEMS-HF

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Feb 29, 2016
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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