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CardioMEMS HF System Post Approval Study

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.
 
ClinicalTrials.gov Identifier: NCT02279888
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

Condition or disease Intervention/treatment
Heart Failure Left-Sided Heart Failure Congestive Heart Failure Device: CardioMEMS HF System

Detailed Description:

The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.

Study Design
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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CardioMEMS HF System Post Approval Study
Actual Study Start Date : January 2015
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort Intervention/treatment
CardioMEMS HF System Group
Patients implanted with a CardioMEMS HF System.
 Device: CardioMEMS HF System
Pulmonary artery pressure sensor


Outcome Measures
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Primary Outcome Measures :
  1. freedom from device/system related complication [ Time Frame: two year ]
  2. freedom from pressure sensor failure [ Time Frame: two year ]
  3. heart failure hospitalization rate [ Time Frame: one year ]

Other Outcome Measures:
  1. all-cause mortality [ Time Frame: one year ]
  2. heart failure hospitalization or death rate [ Time Frame: one year ]

Eligibility Criteria
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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 with NYHA class III heart failure
Criteria

Inclusion Criteria:

  • Diagnosis of NYHA class III heart failure
  • At least 1 heart failure hospitalization within previous 12 months
  • Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
  • BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
  • Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)

Exclusion Criteria:

  • Active infection
  • History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  • Inability to tolerate a right heart catheterization
  • A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
  • Cardiac resynchronization device (CRT) implanted within previous 3 months
  • Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  • Congenital heart disease or mechanical right heart valve
  • Likely to undergo heart transplantation or VAD within the next 6 months
  • Known coagulation disorders
  • Hypersensitivity or allergy to aspirin, and/or clopidogrel
Contacts and Locations
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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): NCT02279888


Locations
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United States, West Virginia
West Virginia Heart Institute
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Lynne Stevenson, MD Brigham and Women's
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02279888    
Other Study ID Numbers: SJM-CIP-10035
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Abbott Medical Devices:
Pulmonary Artery Pressure Monitoring
Implantable Hemodynamic Monitor
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases