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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02693691
Recruitment Status : Active, not recruiting
First Posted : February 29, 2016
Last Update Posted : June 21, 2018
Information provided by (Responsible Party):
St. Jude Medical

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

Condition or disease Intervention/treatment Phase
Heart Failure Device: CardioMEMS HF System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CardioMEMS European Monitoring Study for Heart Failure
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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

Primary Outcome Measures :
  1. freedom from device/system related complications [ Time Frame: one year ]
  2. freedom from pressure sensor failure [ Time Frame: one year ]
  3. % successful pulmonary artery pressure data transmissions [ Time Frame: one year ]

Secondary Outcome Measures :
  1. HF hospitalization rate [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02693691

Klinukum Coburg
Coburg, Bavaria, Germany, 96450
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Christiane Angermann, Prof. Dr. Deutsches Zentrum für Herzinsuffizienz Würzburg
Principal Investigator: Michael Boehm, Prof. Dr. University Hospital, Saarland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT02693691     History of Changes
Other Study ID Numbers: SJM-CIP-10105
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases