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Trial record 1 of 1 for:    NCT00531661
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CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION)

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ClinicalTrials.gov Identifier: NCT00531661
Recruitment Status : Completed
First Posted : September 19, 2007
Results First Posted : April 9, 2013
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
CardioMEMS

Tracking Information
First Submitted Date  ICMJE September 18, 2007
First Posted Date  ICMJE September 19, 2007
Results First Submitted Date  ICMJE November 16, 2012
Results First Posted Date  ICMJE April 9, 2013
Last Update Posted Date January 28, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
  • Rate of Heart Failure Related (HFR) Hospitalizations [ Time Frame: 6 months ]
  • Freedom From a Device/System-related Complication (DSRC). [ Time Frame: 6 months ]
    A DSRC is an adverse event that is, or is possibly, related to the HF Pressure Measurement System and at least one the following:
    • is treated with invasive means (other than intramuscular medication or a right heart catheterization with a Swan-Ganz measurement which is used for diagnostic purposes)
    • results in the death of the subject
    • results in the explant of the device
  • Freedom From Pressure Sensor Failure [ Time Frame: 6 months ]
    A pressure sensor failure occurs when the sensor malfunctions to the point that no readings can be obtained from it after all attempts are exhausted including troubleshooting the system to rule out any problems with the electronic components.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
  • Change From Baseline in Pulmonary Artery Mean Pressure [ Time Frame: 6 months ]
    Change from baseline in pulmonary artery mean pressure was calculated using an area under the curve (AUC) methodology. All patients were instructed to take daily home readings for 180 days. By patient, a baseline average for the first 7 days of home readings was calculated. The difference between baseline and each daily reading was then determined and a corresponding daily AUC value was calculated. Finally, all daily AUC values were summed over the entire 180 day period resulting in a total AUC per patient. These data were aggregated for each randomization group and then compared. The unit of measure is mmHg x Days.
  • Proportion of Patients Hospitalized for Heart Failure [ Time Frame: 6 months ]
  • Days Alive Outside of the Hospital [ Time Frame: 6 months ]
  • Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ) [ Time Frame: 6 months ]
    THe MLHFQ is patient self-assessment of how heart failure affects his or her daily life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHFQ questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired. Total scores are provided as sums. The total score scale range is 0 - 105. A lower total score is indicative of better quality of life.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2013)
  • Rate of HFR Hospitalizations [ Time Frame: Study duration: average patient follow-up of 15 months ]
  • Freedom From a Device/System-related Complication (DSRC) [ Time Frame: Study duration: average patient follow-up of 15 months ]
  • Freedom From Pressure Sensor Failure [ Time Frame: Study duration: average patient follow-up of 15 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Official Title  ICMJE CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Brief Summary This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Congestive
Intervention  ICMJE Device: HF Pressure Measurement System
A pressure sensor is intended to be implanted into the pulmonary artery at the time of Swan-Ganz catheterization.
Study Arms  ICMJE
  • Active Comparator: TREATMENT Group
    Standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
    Intervention: Device: HF Pressure Measurement System
  • Placebo Comparator: CONTROL Group
    Standard of care HF management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2007)
550
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
  2. Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
  3. Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
  4. At least 1 HF hospitalization within 12 months of Screening Visit
  5. Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

  1. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
  2. Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
  3. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
  4. Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
  5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
  6. Subjects likely to undergo heart transplantation within 6 months of Screening Visit
  7. Subjects with congenital heart disease or mechanical right heart valve(s)
  8. Subjects with known coagulation disorders
  9. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00531661
Other Study ID Numbers  ICMJE CM-06-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CardioMEMS
Study Sponsor  ICMJE CardioMEMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Phillip Adamson, MD, FACC Oklahoma Heart Hospital
Principal Investigator: William T Abraham, MD, FACC Ohio State University
PRS Account CardioMEMS
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP