Heart Failure
Conditions
Brief summary
The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.
Interventions
DEVICECardioMEMS HF System
Pulmonary Artery Pressure Monitoring
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual * ≥ 18 years of age * Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation * Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant * Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated * Written informed consent obtained from subject
Exclusion criteria
* Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted * Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Device/System Related Complications | one year | This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as 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 cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant. |
| Freedom From Pressure Sensor Failure | one year | This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant. |
| Percent of Successful Pulmonary Artery Pressure Data Transmissions | one year | Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Hospitalization (HFH) Rate | one year | Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant. |
Countries
Germany
Participant flow
Recruitment details
The study enrolled a total of 239 subjects at 31 investigational sites in Germany, The Netherlands, and Ireland. The first subject was enrolled on 13 May 2016 and the last subject was enrolled on 29 March 2018. The last 12-month follow-up was completed on 19 March 2019. Data was collected until the database closure date, 28 June 2019.
Pre-assignment details
Three of the 239 subjects enrolled withdrew before implantation was attempted. Of the 236 subjects who had an attempted implant, two subjects were not implanted. One subject was not implanted because there was a failure to meet screening criteria and the other subject experienced an AE during the implant procedure and was not implanted.
Participants by arm
| Arm | Count |
|---|---|
| CardioMEMS HF System Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.
CardioMEMS HF System: Pulmonary Artery Pressure Monitoring | 239 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extended Follow-Up (Until Last pt 12M) | Death | 12 |
| Extended Follow-Up (Until Last pt 12M) | Physician Decision | 1 |
| Extended Follow-Up (Until Last pt 12M) | Withdrawal by Subject | 11 |
| Primary Endpoint Analysis (First 12M) | Adverse Event | 1 |
| Primary Endpoint Analysis (First 12M) | Death | 30 |
| Primary Endpoint Analysis (First 12M) | Physician Decision | 7 |
| Primary Endpoint Analysis (First 12M) | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | CardioMEMS HF System | — |
|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 10.7 | — |
| BMI | 28.8 kg/m^2 STANDARD_DEVIATION 5.3 | — |
| Ejection Fraction HFpEF (EF ≥ 40%) | 68 Participants | — |
| Ejection Fraction HFrEF (EF < 40%) | 168 Participants | — |
| Ejection Fraction Unknown | 3 Participants | — |
| HF Etiology Ischemic Cardiomyopathy | 128 Participants | — |
| HF Etiology Non-Ischemic Cardiomyopathy | 87 Participants | — |
| HF Etiology Unknown | 24 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 216 participants | — |
| Region of Enrollment Ireland | 4 participants | — |
| Region of Enrollment Netherlands | 19 participants | — |
| Sex: Female, Male Female | 53 Participants | — |
| Sex: Female, Male Male | 186 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 42 / 234 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 184 / 239 |
Outcome results
Primary
Freedom From Device/System Related Complications
This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as 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 cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant.
Time frame: one year
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CardioMEMS HF System | Freedom From Device/System Related Complications | 98.3 percentage of patients |
Primary
Freedom From Pressure Sensor Failure
This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.
Time frame: one year
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CardioMEMS HF System | Freedom From Pressure Sensor Failure | 99.6 percentage of patients |
Primary
Percent of Successful Pulmonary Artery Pressure Data Transmissions
Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months.
Time frame: one year
Population: All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CardioMEMS HF System | Percent of Successful Pulmonary Artery Pressure Data Transmissions | 91.7 percentage of successful transmissions | Standard Deviation 13 |
Secondary
Heart Failure Hospitalization (HFH) Rate
Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant.
Time frame: one year
Population: All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CardioMEMS HF System | Heart Failure Hospitalization (HFH) Rate | 0.38 Hazard Ratio |