Congestive Heart Failure, Heart Failure, Left-Sided Heart Failure
Conditions
Keywords
Pulmonary Artery Pressure Monitoring, Implantable Hemodynamic Monitor
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.
Interventions
DEVICECardioMEMS HF System
Pulmonary artery pressure sensor
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Device and/or System Related Complication (DSRC) | two years | As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity. |
| Freedom From Pressure Sensor Failure | two year | A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity. |
| Heart Failure Hospitalization (HFH) Rate | one year | Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Training Evaluation - Freedom From DRSC in Academic and Community Hospitals | 2 Years | To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals. |
| Overall Survival | one and two years | Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method. |
| Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals | 2 Years | To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals. |
| Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals | 2 Years | To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals. |
| Heart Failure Hospitalization or Death Rate | one year | The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met. |
| Patient Compliance | One and Two Years | Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings |
Countries
United States
Participant flow
Pre-assignment details
All patients who were consented and had an attempted implant (n=1214) are included in all safety analyses. To be considered enrolled in the study, subjects must sign consent and have the CardioMEMS PA Sensor successfully implanted (n=1200).
Participants by arm
| Arm | Count |
|---|---|
| CardioMEMS HF System Group Patients who underwent a CardioMEMS HF System implant procedure
CardioMEMS HF System: Pulmonary artery pressure sensor | 1,214 |
| Total | 1,214 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 326 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Not implanted | 14 |
| Overall Study | Physician Decision | 62 |
| Overall Study | Subject Non-compliance | 43 |
| Overall Study | Visit not performed | 26 |
| Overall Study | Withdrawal by Subject | 38 |
Baseline characteristics
| Characteristic | CardioMEMS HF System Group |
|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 11.7 |
| Body Mass Index (BMI) | 31.7 kg/m^2 STANDARD_DEVIATION 7.9 |
| Left Ventricular Ejection Fraction (LVEF) | 38.8 % ejected STANDARD_DEVIATION 17.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 175 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 1004 Participants |
| Region of Enrollment United States | 1214 participants |
| Sex: Female, Male Female | 457 Participants |
| Sex: Female, Male Male | 757 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 970 / 1,214 |
| other Total, other adverse events | 62 / 1,214 |
| serious Total, serious adverse events | 970 / 1,214 |
Outcome results
Primary
Freedom From Device and/or System Related Complication (DSRC)
As defined in the study protocol, a DSRC is an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); results in death of the subject; results in the explant of the device. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.
Time frame: two years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CardioMEMS HF System Safety Group | Freedom From Device and/or System Related Complication (DSRC) | 1209 Participants |
p-value: <0.0001t-test, 2 sided
Primary
Freedom From Pressure Sensor Failure
A Sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. The primary safety analyses were based on the following objective performance criteria: a) the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80% and b) the lower limit of the two-sided 95% confidence interval on the freedom from pressure sensor failure rate at 24 months is greater than 90%. These primary safety endpoints were tested hierarchically, testing for freedom from DSRCs first, in order to control for multiplicity.
Time frame: two year
Population: Subjects implanted with CardioMEMS device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CardioMEMS HF System Safety Group | Freedom From Pressure Sensor Failure | 1199 Participants |
Primary
Heart Failure Hospitalization (HFH) Rate
Annualized HFH rate parameter at 1 year versus the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then the primary effectiveness endpoint was met.
Time frame: one year
Population: Patients implanted with a CardioMEMS PA Sensor
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CardioMEMS HF System Safety Group | Heart Failure Hospitalization (HFH) Rate | 1 Year HFH Rate prior implant (Events per patient year) | 1.249 hospitalization events per patient year |
| CardioMEMS HF System Safety Group | Heart Failure Hospitalization (HFH) Rate | 1 Year HFH Rate post implant (Events per patient year) | 0.535 hospitalization events per patient year |
p-value: <0.000195% CI: [0.39, 0.47]Andersen-Gill
Other Pre-specified
Heart Failure Hospitalization or Death Rate
The annualized HFH or death rate parameter at 1 year was compared to the HFH rate in the year prior to enrollment using an Andersen-Gill method for recurrent events and robust sandwich variances to account for within-subject correlation. If the two-sided, upper 95% confidence interval for the hazard ratio (HR) is less than 1.0, then this effectiveness endpoint was met.
Time frame: one year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CardioMEMS HF System Safety Group | Heart Failure Hospitalization or Death Rate | Annualized HFH + Death 1 Year prior implant (Events per patient year) | 1.249 events per patient year |
| CardioMEMS HF System Safety Group | Heart Failure Hospitalization or Death Rate | Annualized HFH + Death 1 Year post implant (Events per patient year) | 0.708 events per patient year |
p-value: <0.000195% CI: [0.52, 0.62]Andersen-Gill
Other Pre-specified
Overall Survival
Survival at 1 year and 24 years post-implant is reported using the Kaplan-Meier method.
Time frame: one and two years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CardioMEMS HF System Safety Group | Overall Survival | Survival at 1 year post implant | 83.9 survival percentage |
| CardioMEMS HF System Safety Group | Overall Survival | Survival at 2 years post implant | 71.0 survival percentage |
Other Pre-specified
Patient Compliance
Total daily readings divided by total number possible for daily readings as well as total weekly readings divided by total possible weekly readings
Time frame: One and Two Years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CardioMEMS HF System Safety Group | Patient Compliance | Weekly Compliance at 1 Year | 92.8 percentage of compliance | Standard Deviation 15.8 |
| CardioMEMS HF System Safety Group | Patient Compliance | Weekly Compliance at 2 Years | 90.0 percentage of compliance | Standard Deviation 18.2 |
Other Pre-specified
Training Evaluation - Freedom From DRSC in Academic and Community Hospitals
To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.
Time frame: 2 Years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CardioMEMS HF System Safety Group | Training Evaluation - Freedom From DRSC in Academic and Community Hospitals | 428 Participants |
| Community Centers Population | Training Evaluation - Freedom From DRSC in Academic and Community Hospitals | 781 Participants |
Other Pre-specified
Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals
To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.
Time frame: 2 Years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CardioMEMS HF System Safety Group | Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals | 425 Participants |
| Community Centers Population | Training Evaluation - Freedom From Pressure Sensor Failure in Academic and Community Hospitals | 774 Participants |
Other Pre-specified
Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals
To assess the effectiveness of the training program, the safety and effectiveness results were analyzed for Academic Hospitals versus Community Hospitals.
Time frame: 2 Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CardioMEMS HF System Safety Group | Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals | HF hospitalizations one year prior implant | 588 HF hospitalizations |
| CardioMEMS HF System Safety Group | Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals | HF hospitalizations one year prost implant | 245 HF hospitalizations |
| Community Centers Population | Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals | HF hospitalizations one year prior implant | 1012 HF hospitalizations |
| Community Centers Population | Training Evaluation - HF Hospitalizations Reduction in Academic and Community Hospitals | HF hospitalizations one year prost implant | 383 HF hospitalizations |