Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION)

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: 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Heart Failure, Congestive
Intervention Device: HF Pressure Measurement System
Enrollment 550
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control
Hide Arm/Group Description TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System CONTROL group: standard of care HF management
Period Title: 6 Months
Started 270 280
Completed 244 254
Not Completed 26 26
Period Title: Study Duration: 15 Months Avg. Follow-up
Started 244 254
Completed 186 197
Not Completed 58 57
Arm/Group Title Treatment Control Total
Hide Arm/Group Description TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System CONTROL group: standard of care HF management Total of all reporting groups
Overall Number of Baseline Participants 270 280 550
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 280 participants 550 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
150
  55.6%
155
  55.4%
305
  55.5%
>=65 years
120
  44.4%
125
  44.6%
245
  44.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 270 participants 280 participants 550 participants
61.3  (13.0) 61.8  (12.7) 61.6  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 270 participants 280 participants 550 participants
Female
76
  28.1%
75
  26.8%
151
  27.5%
Male
194
  71.9%
205
  73.2%
399
  72.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 270 participants 280 participants 550 participants
270 280 550
1.Primary Outcome
Title Rate of Heart Failure Related (HFR) Hospitalizations
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Measure Type: Number
Unit of Measure: HFR hospitalizations/patient/6 months
0.32 0.44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
2.Primary Outcome
Title Freedom From a Device/System-related Complication (DSRC).
Hide Description

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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device as well as patients where an implant was attempted. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC). This population includes 550 implanted patients + 25 patient attempts.
Arm/Group Title Entire Study Cohort
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 550
Overall Number of Units Analyzed
Type of Units Analyzed: Implantation Cases
575
Measure Type: Number
Unit of Measure: cases
567
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Study Cohort
Comments

Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:

Null: (Freedom from device / system-related complications) ≤ 80%

Alternative: (Freedom from device / system-related complications) > 80%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact test of binomial proportions
Comments P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.
3.Primary Outcome
Title Freedom From Pressure Sensor Failure
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
This Safety Endpoint was prespecified as an aggregate analysis of all patients implanted with the device. Results are not presented as an inter-arm comparison but rather against an objective performance criteria (OPC).
Arm/Group Title Entire Randomized Study Cohort
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 550
Measure Type: Number
Unit of Measure: participants
550
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Entire Randomized Study Cohort
Comments

Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:

Null: (Freedom from device / system-related complications) ≤ 90%

Alternative: (Freedom from device / system-related complications) > 90%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact test of binomial proportions
Comments P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.
4.Secondary Outcome
Title Change From Baseline in Pulmonary Artery Mean Pressure
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Mean (Standard Deviation)
Unit of Measure: mmHg * days
-155.7  (1088.0) 33.1  (951.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Patients Hospitalized for Heart Failure
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Measure Type: Number
Unit of Measure: participants
55 80
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0292
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Days Alive Outside of the Hospital
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Mean (Standard Deviation)
Unit of Measure: days
174.4  (31.1) 172.1  (37.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0280
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.2  (26.4) 50.6  (24.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Rate of HFR Hospitalizations
Hide Description [Not Specified]
Time Frame Study duration: average patient follow-up of 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
CONTROL group: standard of care HF management
Overall Number of Participants Analyzed 270 280
Measure Type: Number
Unit of Measure: HFR hospitalizations/patient-year
0.46 0.73
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Freedom From a Device/System-related Complication (DSRC)
Hide Description [Not Specified]
Time Frame Study duration: average patient follow-up of 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Duration Study Cohort
Hide Arm/Group Description:
Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
Overall Number of Participants Analyzed 498
Measure Type: Number
Unit of Measure: participants
498
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Full Duration Study Cohort
Comments

Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:

Null: (Freedom from device / system-related complications) ≤ 80%

Alternative: (Freedom from device / system-related complications) > 80%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact test of binomial proportions
Comments P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.
10.Other Pre-specified Outcome
Title Freedom From Pressure Sensor Failure
Hide Description [Not Specified]
Time Frame Study duration: average patient follow-up of 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Duration Study Cohort
Hide Arm/Group Description:
Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
Overall Number of Participants Analyzed 498
Measure Type: Number
Unit of Measure: participants
498
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Full Duration Study Cohort
Comments

Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:

Null: (Freedom from device / system-related complications) ≤ 90%

Alternative: (Freedom from device / system-related complications) > 90%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method exact test of binomial proportions
Comments P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide Arm/Group Description TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System CONTROL group: standard of care HF management
All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   121/270 (44.81%)      155/280 (55.36%)    
Cardiac disorders     
Cardiac Disorders  76/270 (28.15%)  144 101/280 (36.07%)  187
Gastrointestinal disorders     
gastrointestinal  12/270 (4.44%)  18 12/280 (4.29%)  19
General disorders     
general disorders  9/270 (3.33%)  10 12/280 (4.29%)  15
Infections and infestations     
infections  22/270 (8.15%)  27 22/280 (7.86%)  24
Metabolism and nutrition disorders     
metabolism and nutrition  14/270 (5.19%)  16 12/280 (4.29%)  13
Nervous system disorders     
nervous system  12/270 (4.44%)  16 14/280 (5.00%)  20
Renal and urinary disorders     
renal and urinary  19/270 (7.04%)  19 12/280 (4.29%)  13
Respiratory, thoracic and mediastinal disorders     
Respiratory  22/270 (8.15%)  26 25/280 (8.93%)  31
Surgical and medical procedures     
surgical  10/270 (3.70%)  11 11/280 (3.93%)  13
Vascular disorders     
vascular  17/270 (6.30%)  21 15/280 (5.36%)  16
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   175/270 (64.81%)      174/280 (62.14%)    
Blood and lymphatic system disorders     
blood and lymphatic system  17/270 (6.30%)  20 13/280 (4.64%)  16
Cardiac disorders     
cardiac  47/270 (17.41%)  73 38/280 (13.57%)  58
Gastrointestinal disorders     
gastrointestinal  42/270 (15.56%)  61 34/280 (12.14%)  49
General disorders     
general disorders  35/270 (12.96%)  44 24/280 (8.57%)  30
Infections and infestations     
infections  38/270 (14.07%)  50 46/280 (16.43%)  56
Injury, poisoning and procedural complications     
injury  15/270 (5.56%)  17 12/280 (4.29%)  13
Investigations     
investigations  19/270 (7.04%)  25 16/280 (5.71%)  19
Metabolism and nutrition disorders     
metabolism and nutrition  43/270 (15.93%)  57 29/280 (10.36%)  33
Musculoskeletal and connective tissue disorders     
musculoskeletal  29/270 (10.74%)  34 27/280 (9.64%)  33
Nervous system disorders     
nervous system  38/270 (14.07%)  47 24/280 (8.57%)  32
Psychiatric disorders     
psychiatric  17/270 (6.30%)  19 12/280 (4.29%)  14
Renal and urinary disorders     
renal and urinary  25/270 (9.26%)  33 21/280 (7.50%)  22
Respiratory, thoracic and mediastinal disorders     
respiratory  42/270 (15.56%)  51 44/280 (15.71%)  62
Skin and subcutaneous tissue disorders     
skin and subcutaneous tissue  15/270 (5.56%)  15 13/280 (4.64%)  15
Vascular disorders     
vascular  24/270 (8.89%)  30 21/280 (7.50%)  23
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jordan Bauman
Organization: CardioMEMS, Inc.
Phone: 4043458235
EMail: jbauman@cardiomems.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: CardioMEMS
ClinicalTrials.gov Identifier: NCT00531661    
Other Study ID Numbers: CM-06-04
First Submitted: September 18, 2007
First Posted: September 19, 2007
Results First Submitted: November 16, 2012
Results First Posted: April 9, 2013
Last Update Posted: January 28, 2015