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Registry of Patients With CardioMEMS

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ClinicalTrials.gov Identifier: NCT02729922
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
CardioMEMS is an implantable wireless hemodynamic monitoring system which can transmit the pulmonary artery pressure. This device is FDA approved to be used as a diagnostic tool to help management of selected heart failure patients. Heart failure patients with NYHA class III heart failure, irrespective of the left ventricular ejection fraction, and a previous hospital admission for heart failure in the past 12 months, without stage IV or V chronic kidney disease are candidates to receive a CardioMEMS device. Our goal is to create a registry of all patients that receive a CardioMEMS device and monitor outcomes, primarily heart failure hospitalizations, heart failure related quality of life and re-admissions.

Condition or disease Intervention/treatment
Heart Failure, Congestive Device: Cardiomems

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Registry of Patients With CardioMEMS
Study Start Date : March 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: Cardiomems
    Eligible patients will undergo implantation of a pulmonary artery sensor (CardioMEMS), a wireless implantable hemodynamic monitoring system in the cardiac catheterization laboratory. This system has a passive wireless, radiofrequency sensor without batteries or leads. Patients transmit data through a device in their home that interacts wirelessly with the sensor. Clinicians retrieve this data via a web interface to use in making management decisions for patients.


Primary Outcome Measures :
  1. Heart Failure Hospitalizations [ Time Frame: 1 year ]
    Number of admissions to the hospital for the treatment of heart failure


Secondary Outcome Measures :
  1. Heart Failure Related Quality of Life [ Time Frame: 1 year ]
    Minnesota Living with Heart Failure Questionaire


Other Outcome Measures:
  1. Heart Failure Outpatient Visits [ Time Frame: 1 year ]
    Number of outpatient visits to monitor or treat heart failure



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
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years or older with New York Heart Association functional class III heart failure for at least three months, irrespective of left ventricular ejection fraction or cause, and a hospitalization for heart failure within the past 12 months who are on optimal medical and device management. Patients being referred for the placement of a Cardiomems device by their clinical Heart Failure Cardiologist will be invited to participate in the registry.
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • NYHA class III heart failure
  • Heart Failure Hospitalization in the last 12 months
  • Optimal heart failure medical and device therapies per national heart failure guidelines

Exclusion Criteria:

  • History of recurrent pulmonary embolism or deep vein thrombosis
  • Cardiac resynchronization device placement in the last three months
  • Stage IV or V chronic kidney disease
  • Unable to take anti-platelet or anti-coagulation therapy

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 ClinicalTrials.gov identifier (NCT number): NCT02729922


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Lee R Goldberg, MD, MPH University of Pennsylvania
Additional Information:

Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02729922    
Other Study ID Numbers: 824716
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases