Trial Outcomes & Findings for CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (NCT NCT00531661)

NCT ID: NCT00531661

Last Updated: 2015-01-28

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 550 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-01-28

Participant Flow

Participant milestones

Measure	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
6 Months STARTED	270	280
6 Months COMPLETED	244	254
6 Months NOT COMPLETED	26	26
Study Duration: 15 Months Avg. Follow-up STARTED	244	254
Study Duration: 15 Months Avg. Follow-up COMPLETED	186	197
Study Duration: 15 Months Avg. Follow-up NOT COMPLETED	58	57

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management	Total n=550 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=5 Participants	155 Participants n=7 Participants	305 Participants n=5 Participants
Age, Categorical >=65 years	120 Participants n=5 Participants	125 Participants n=7 Participants	245 Participants n=5 Participants
Age, Continuous	61.3 years STANDARD_DEVIATION 13.0 • n=5 Participants	61.8 years STANDARD_DEVIATION 12.7 • n=7 Participants	61.6 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	75 Participants n=7 Participants	151 Participants n=5 Participants
Sex: Female, Male Male	194 Participants n=5 Participants	205 Participants n=7 Participants	399 Participants n=5 Participants
Region of Enrollment United States	270 participants n=5 Participants	280 participants n=7 Participants	550 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Rate of Heart Failure Related (HFR) Hospitalizations	0.32 HFR hospitalizations/patient/6 months	0.44 HFR hospitalizations/patient/6 months

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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

Outcome measures

Measure	Treatment n=575 Implantation Cases 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
Freedom From a Device/System-related Complication (DSRC).	567 cases	—

PRIMARY outcome

Timeframe: 6 months

Population: 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).

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.

Outcome measures

Measure	Treatment n=550 Participants 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
Freedom From Pressure Sensor Failure	550 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Change From Baseline in Pulmonary Artery Mean Pressure	-155.7 mmHg * days Standard Deviation 1088.0	33.1 mmHg * days Standard Deviation 951.7

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Proportion of Patients Hospitalized for Heart Failure	55 participants	80 participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Days Alive Outside of the Hospital	174.4 days Standard Deviation 31.1	172.1 days Standard Deviation 37.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Quality of Life - Minnesota Living With Heart Failure Questionnaire (MLHFQ)	45.2 units on a scale Standard Deviation 26.4	50.6 units on a scale Standard Deviation 24.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Study duration: average patient follow-up of 15 months

Outcome measures

Measure	Treatment n=270 Participants TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 Participants CONTROL group: standard of care HF management
Rate of HFR Hospitalizations	0.46 HFR hospitalizations/patient-year	0.73 HFR hospitalizations/patient-year

OTHER_PRE_SPECIFIED outcome

Timeframe: Study duration: average patient follow-up of 15 months

Outcome measures

Measure	Treatment n=498 Participants 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
Freedom From a Device/System-related Complication (DSRC)	498 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Study duration: average patient follow-up of 15 months

Outcome measures

Measure	Treatment n=498 Participants 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
Freedom From Pressure Sensor Failure	498 participants	—

Adverse Events

Treatment

Serious events: 121 serious events

Other events: 175 other events

Deaths: 0 deaths

Control

Serious events: 155 serious events

Other events: 174 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=270 participants at risk TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 participants at risk CONTROL group: standard of care HF management
Cardiac disorders Cardiac Disorders	28.1% 76/270 • Number of events 144	36.1% 101/280 • Number of events 187
Respiratory, thoracic and mediastinal disorders Respiratory	8.1% 22/270 • Number of events 26	8.9% 25/280 • Number of events 31
Infections and infestations infections	8.1% 22/270 • Number of events 27	7.9% 22/280 • Number of events 24
Vascular disorders vascular	6.3% 17/270 • Number of events 21	5.4% 15/280 • Number of events 16
Renal and urinary disorders renal and urinary	7.0% 19/270 • Number of events 19	4.3% 12/280 • Number of events 13
Metabolism and nutrition disorders metabolism and nutrition	5.2% 14/270 • Number of events 16	4.3% 12/280 • Number of events 13
Nervous system disorders nervous system	4.4% 12/270 • Number of events 16	5.0% 14/280 • Number of events 20
Gastrointestinal disorders gastrointestinal	4.4% 12/270 • Number of events 18	4.3% 12/280 • Number of events 19
General disorders general disorders	3.3% 9/270 • Number of events 10	4.3% 12/280 • Number of events 15
Surgical and medical procedures surgical	3.7% 10/270 • Number of events 11	3.9% 11/280 • Number of events 13

Other adverse events

Measure	Treatment n=270 participants at risk TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System	Control n=280 participants at risk CONTROL group: standard of care HF management
Respiratory, thoracic and mediastinal disorders respiratory	15.6% 42/270 • Number of events 51	15.7% 44/280 • Number of events 62
Cardiac disorders cardiac	17.4% 47/270 • Number of events 73	13.6% 38/280 • Number of events 58
Infections and infestations infections	14.1% 38/270 • Number of events 50	16.4% 46/280 • Number of events 56
Gastrointestinal disorders gastrointestinal	15.6% 42/270 • Number of events 61	12.1% 34/280 • Number of events 49
Metabolism and nutrition disorders metabolism and nutrition	15.9% 43/270 • Number of events 57	10.4% 29/280 • Number of events 33
Nervous system disorders nervous system	14.1% 38/270 • Number of events 47	8.6% 24/280 • Number of events 32
General disorders general disorders	13.0% 35/270 • Number of events 44	8.6% 24/280 • Number of events 30
Musculoskeletal and connective tissue disorders musculoskeletal	10.7% 29/270 • Number of events 34	9.6% 27/280 • Number of events 33
Renal and urinary disorders renal and urinary	9.3% 25/270 • Number of events 33	7.5% 21/280 • Number of events 22
Vascular disorders vascular	8.9% 24/270 • Number of events 30	7.5% 21/280 • Number of events 23
Investigations investigations	7.0% 19/270 • Number of events 25	5.7% 16/280 • Number of events 19
Blood and lymphatic system disorders blood and lymphatic system	6.3% 17/270 • Number of events 20	4.6% 13/280 • Number of events 16
Psychiatric disorders psychiatric	6.3% 17/270 • Number of events 19	4.3% 12/280 • Number of events 14
Skin and subcutaneous tissue disorders skin and subcutaneous tissue	5.6% 15/270 • Number of events 15	4.6% 13/280 • Number of events 15
Injury, poisoning and procedural complications injury	5.6% 15/270 • Number of events 17	4.3% 12/280 • Number of events 13

Additional Information

Jordan Bauman

CardioMEMS, Inc.

Phone: 4043458235

Email: jbauman@cardiomems.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place