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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

Tracking Information
First Submitted Date October 29, 2014
First Posted Date October 31, 2014
Last Update Posted Date April 7, 2020
Actual Study Start Date January 2015
Actual Primary Completion Date October 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2014)
  • freedom from device/system related complication [ Time Frame: two year ]
  • freedom from pressure sensor failure [ Time Frame: two year ]
  • heart failure hospitalization rate [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2014)
  • all-cause mortality [ Time Frame: one year ]
  • heart failure hospitalization or death rate [ Time Frame: one year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title CardioMEMS HF System Post Approval Study
Official Title CardioMEMS HF System Post Approval Study
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with NYHA class III heart failure
Condition
  • Heart Failure
  • Left-Sided Heart Failure
  • Congestive Heart Failure
Intervention Device: CardioMEMS HF System
Pulmonary artery pressure sensor
Study Groups/Cohorts CardioMEMS HF System Group
Patients implanted with a CardioMEMS HF System.
Intervention: Device: CardioMEMS HF System
Publications * Shavelle DM, Desai AS, Abraham WT, Bourge RC, Raval N, Rathman LD, Heywood JT, Jermyn RA, Pelzel J, Jonsson OT, Costanzo MR, Henderson JD, Brett ME, Adamson PB, Stevenson LW; CardioMEMS Post-Approval Study Investigators. Lower Rates of Heart Failure and All-Cause Hospitalizations During Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure: One-Year Outcomes From the CardioMEMS Post-Approval Study. Circ Heart Fail. 2020 Aug 6:CIRCHEARTFAILURE119006863. doi: 10.1161/CIRCHEARTFAILURE.119.006863. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2014)
1200
Original Estimated Enrollment Same as current
Actual Study Completion Date February 3, 2020
Actual Primary Completion Date October 11, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02279888
Other Study ID Numbers SJM-CIP-10035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Study Chair: Lynne Stevenson, MD Brigham and Women's
PRS Account Abbott Medical Devices
Verification Date April 2020