Congestive Heart Failure, Heart Failure, Left-Sided Heart Failure
Conditions
Brief summary
The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Class III Heart Failure in a commercial setting.
Interventions
DEVICECardioMEMS HF System
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
1. Written informed consent obtained from subject 2. ≥ 18 years of age 3. Diagnosis of NYHA Class III Heart Failure 4. At least 1 HF hospitalization within 12 months of Baseline visit 5. Subjects 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 subject is intolerant to beta blockers, ACE-I or ARB. 6. Subjects with a BMI ≤ 35. Subjects 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. 7. Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC) 8. Subjects willing and able to comply with the follow-up requirements of the study
Exclusion criteria
1. Subjects with an active infection 2. Subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis 3. Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization 4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit 5. Subjects with Cardiac Resynchronization Device (CRT) implanted \< 3 months prior to enrollment 6. Subjects with a Glomerular Filtration Rate (GFR) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis 7. Subjects with congenital heart disease or mechanical right heart valve(s) 8. Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit 9. Subjects with known coagulation disorders 10. Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Device/System Related Complications | Two year | A device/System related complication (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: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device. |
| 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. |
| Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | One year | HFH events at 1 year versus the HFH events in the year prior to enrollment |
Countries
Australia, Belgium, Denmark, France, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Effectiveness Population Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Attempted Implant unsuccessful | 5 |
| Overall Study | Death | 90 |
| Overall Study | Not Implanted due to COVID restrictions | 1 |
| Overall Study | Not implanted due to physician's decision | 1 |
| Overall Study | Physician Decision | 13 |
| Overall Study | Withdrawal by Subject | 4 |
| Overall Study | Withdrawn Prior Implant Attempt | 17 |
Baseline characteristics
| Characteristic | Effectiveness Population | — |
|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 11.7 | — |
| Chronic kidney disease Not collected/Not reported | 88 Participants | — |
| Chronic kidney disease Stage 3 | 187 Participants | — |
| Chronic kidney disease Stage 4 | 23 Participants | — |
| Chronic kidney disease Stage 5 | 1 Participants | — |
| Chronic obstructive pulmonary disease | 67 Participants | — |
| CRT/CRT-D | 87 Participants | — |
| Diabetes Mellitus | 129 Participants | — |
| Glomerular filtration rate (eGFR | 51.53 mL/min/1.73 m^2 STANDARD_DEVIATION 19.85 | — |
| Hypertension | 164 Participants | — |
| ICD | 71 Participants | — |
| Ischemic Cardiomyopathy | 137 Participants | — |
| Medications at baseline ACE inhibitor/ARB/ARNi | 255 number of patients taking medication | — |
| Medications at baseline Beta Blocker + ACE inhibitor/ARB/ARNi | 202 number of patients taking medication | — |
| Medications at baseline Beta Blockers | 248 number of patients taking medication | — |
| Medications at baseline Diuretics (all types) | 293 number of patients taking medication | — |
| Medications at baseline Loop Diuretic | 288 number of patients taking medication | — |
| Medications at baseline Mineralocorticoid Receptor Antagonists (MRA) | 66 number of patients taking medication | — |
| Medications at baseline Other diuretics | 133 number of patients taking medication | — |
| Medications at baseline Thiazide Diuretic | 47 number of patients taking medication | — |
| NYHA Class Class I | 0 Participants | — |
| NYHA Class Class II | 0 Participants | — |
| NYHA Class Class III | 299 Participants | — |
| NYHA Class Class IV | 0 Participants | — |
| Preserved Ejection Fraction (EF) | 106 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 81 Participants | — |
| Sex: Female, Male Male | 218 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 90 / 304 |
| other Total, other adverse events | 17 / 304 |
| serious Total, serious adverse events | 225 / 304 |
Outcome results
Primary
Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment.
HFH events at 1 year versus the HFH events in the year prior to enrollment
Time frame: One year
Population: Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Safety Population | Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | Annualized HFH rate in the 12Months prior CardioMEMS implant | 1.59 HFH events per year |
| Safety Population | Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | Annualized HFH rate in the 12Months post CardioMEMS implant | 0.49 HFH events per year |
| Safety Population | Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | Annualized HFH rate post-Implant vs pre-implant | 0.31 HFH events per year |
Primary
Freedom From Device/System Related Complications
A device/System related complication (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: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device.
Time frame: Two year
Population: Patients who signed the study Informed Consent and underwent CardioMEMS implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Safety Population | Freedom From Device/System Related Complications | 304 Participants |
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.
Time frame: Two year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Safety Population | Freedom From Pressure Sensor Failure. | 298 Participants |