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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CardioMEMS
ClinicalTrials.gov Identifier:
NCT00531661
First received: September 18, 2007
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Heart Failure, Congestive
Intervention: Device: HF Pressure Measurement System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
Control CONTROL group: standard of care HF management

Participant Flow for 2 periods

Period 1:   6 Months
    Treatment     Control  
STARTED     270     280  
COMPLETED     244     254  
NOT COMPLETED     26     26  

Period 2:   Study Duration: 15 Months Avg. Follow-up
    Treatment     Control  
STARTED     244     254  
COMPLETED     186     197  
NOT COMPLETED     58     57  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
Control CONTROL group: standard of care HF management
Total Total of all reporting groups

Baseline Measures
    Treatment     Control     Total  
Number of Participants  
[units: participants]
  270     280     550  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     150     155     305  
>=65 years     120     125     245  
Age  
[units: years]
Mean ± Standard Deviation
  61.3  ± 13.0     61.8  ± 12.7     61.6  ± 12.8  
Gender  
[units: participants]
     
Female     76     75     151  
Male     194     205     399  
Region of Enrollment  
[units: participants]
     
United States     270     280     550  



  Outcome Measures
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1.  Primary:   Rate of Heart Failure Related (HFR) Hospitalizations   [ Time Frame: 6 months ]

2.  Primary:   Freedom From a Device/System-related Complication (DSRC).   [ Time Frame: 6 months ]

3.  Primary:   Freedom From Pressure Sensor Failure   [ Time Frame: 6 months ]

4.  Secondary:   Change From Baseline in Pulmonary Artery Mean Pressure   [ Time Frame: 6 months ]

5.  Secondary:   Proportion of Patients Hospitalized for Heart Failure   [ Time Frame: 6 months ]

6.  Secondary:   Days Alive Outside of the Hospital   [ Time Frame: 6 months ]

7.  Secondary:   Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)   [ Time Frame: 6 months ]

8.  Other Pre-specified:   Rate of HFR Hospitalizations   [ Time Frame: Study duration: average patient follow-up of 15 months ]

9.  Other Pre-specified:   Freedom From a Device/System-related Complication (DSRC)   [ Time Frame: Study duration: average patient follow-up of 15 months ]

10.  Other Pre-specified:   Freedom From Pressure Sensor Failure   [ Time Frame: Study duration: average patient follow-up of 15 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Jordan Bauman
Organization: CardioMEMS, Inc.
phone: 4043458235
e-mail: jbauman@cardiomems.com


No publications provided


Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT00531661     History of Changes
Other Study ID Numbers: CM-06-04
Study First Received: September 18, 2007
Results First Received: November 16, 2012
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration