Heart Failure
Conditions
Keywords
CardioMEMS, Left Ventricular Assist Device, Hemodynamic Management
Brief summary
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
Detailed description
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and: * Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients under different clinical and physiologic conditions * Characterize the effects of PA pressure on functional status, quality of life, and hospital readmissions of LVAD patients * Evaluate target ranges for PA pressure and assess the impact of medication and pump speed changes on PA pressures
Interventions
DEVICEHemodynamic management using CardioMEMS HF System
Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges
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. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B) 2. Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data) 3. No connectivity or transmission problems with CardioMEMS 4. On HeartMate LVAD support for at least 3 months 5. Age ≥ 18 years
Exclusion criteria
1. Current participation in an investigation that is likely to confound study results or affect study outcome 2. Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial 3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Hall Walk (6MHW) Distance | Six Months | Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in PA Diastolic Pressure From Baseline to 6 Months | six months | Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up. |
| Days PA Diastolic Pressure is in the Pre-specified Target Range | six months | Average number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis. |
| Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | six months | Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis. |
| PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | 6 months | Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test. |
| EQ-5D-5L VAS | six months | Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis. |
| Number and Percent of Participants With All-cause Hospitalizations. | six months | Number and percent of participants who were hospitalized for any cause during follow-up. |
| Number and Percent of Participants With Worsening Heart Failure Events | six months | Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management. |
| New York Heart Association (NYHA) Classification | six months | Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. |
Countries
United States
Participant flow
Recruitment details
The study enrolled a total of 101 subjects at 22 investigational sites in the United States. The first subject was enrolled on 24 August 2017 and enrollment was completed on 20 August 2019. The last 6-month follow-up was completed on 6 March 2020. Data was collected until the database closure date, 3 April 2020.
Participants by arm
| Arm | Count |
|---|---|
| Group A Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS
Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges | 53 |
| Group B Patients with LVAD to implant CardioMEMS device within 72 hours of enrollment, will receive hemodynamic management using CardioMEMS
Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges. | 48 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 4 |
| Overall Study | Enter Hospice Care | 1 | 0 |
| Overall Study | LVAD Explant | 1 | 1 |
| Overall Study | LVAD System Replaced / Exchange | 1 | 0 |
| Overall Study | Transplant | 1 | 1 |
Baseline characteristics
| Characteristic | Group B | Total | Group A |
|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 13.6 | 61.2 years STANDARD_DEVIATION 12.5 | 62.4 years STANDARD_DEVIATION 11.4 |
| Body Mass Index (BMI) | 34.08 kg/m^2 STANDARD_DEVIATION 7.52 | 33.15 kg/m^2 STANDARD_DEVIATION 7.67 | 32.31 kg/m^2 STANDARD_DEVIATION 7.78 |
| EQ-5D-5L VAS | 66.2 score on a scale STANDARD_DEVIATION 20.6 | 68.4 score on a scale STANDARD_DEVIATION 19.8 | 70.3 score on a scale STANDARD_DEVIATION 19.1 |
| Heart Rate | 78.6 beats per minute STANDARD_DEVIATION 16.1 | 78.9 beats per minute STANDARD_DEVIATION 16.9 | 79.2 beats per minute STANDARD_DEVIATION 17.8 |
| Ischemic Cardiomyopathy | 22 Participants | 47 Participants | 25 Participants |
| NYHA Functional Class NYHA Class I | 0 Participants | 2 Participants | 2 Participants |
| NYHA Functional Class NYHA Class II | 6 Participants | 25 Participants | 19 Participants |
| NYHA Functional Class NYHA Class III | 42 Participants | 70 Participants | 28 Participants |
| NYHA Functional Class NYHA Class IV | 0 Participants | 4 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 48 participants | 101 participants | 53 participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Male | 37 Participants | 76 Participants | 39 Participants |
| Six Minute Walk Distance | 243.76 meters STANDARD_DEVIATION 109.58 | 248.26 meters STANDARD_DEVIATION 124.11 | 252.08 meters STANDARD_DEVIATION 136.17 |
| Systemic Diastolic Pressure | 72.6 mmHg STANDARD_DEVIATION 20.3 | 69.1 mmHg STANDARD_DEVIATION 23.3 | 64.7 mmHg STANDARD_DEVIATION 26.6 |
| Systemic Systolic Pressure | 105.7 mmHg STANDARD_DEVIATION 14.9 | 103.4 mmHg STANDARD_DEVIATION 23.1 | 100.6 mmHg STANDARD_DEVIATION 30.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 101 |
| other Total, other adverse events | 3 / 101 |
| serious Total, serious adverse events | 36 / 101 |
Outcome results
Primary
Six Minute Hall Walk (6MHW) Distance
Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
Time frame: Six Months
Population: Six minute hall walk distance measured at 6 months compared to baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Six Minute Hall Walk (6MHW) Distance | -44.9 meters | Standard Deviation 135 |
| Group B | Six Minute Hall Walk (6MHW) Distance | 69.7 meters | Standard Deviation 100.6 |
p-value: 0.001t-test, 2 sided
Other Pre-specified
Change in PA Diastolic Pressure From Baseline to 6 Months
Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up.
Time frame: six months
Population: Change in PA Diastolic pressure from baseline to 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Change in PA Diastolic Pressure From Baseline to 6 Months | 0.6 mmHg | Standard Deviation 4.2 |
| Group B | Change in PA Diastolic Pressure From Baseline to 6 Months | -1.7 mmHg | Standard Deviation 5.6 |
p-value: 0.0931t-test, 2 sided
Other Pre-specified
Days PA Diastolic Pressure is in the Pre-specified Target Range
Average number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis.
Time frame: six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | Days PA Diastolic Pressure is in the Pre-specified Target Range | 28.2 days | Standard Deviation 39 |
Other Pre-specified
EQ-5D-5L VAS
Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis.
Time frame: six months
Population: Change in EQ-5D-5L VAS scores from baseline to 6 months.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Group A | EQ-5D-5L VAS | -1.4 Change in score |
| Group B | EQ-5D-5L VAS | 3.0 Change in score |
Other Pre-specified
New York Heart Association (NYHA) Classification
Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: six months
Population: NYHA class as a continuous variable in which the change in NYHA class is calculated using: NYHA class I =1, class II = 2, class IIIa/IIIb = 3, class IV = 4 and death =5.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Group A | New York Heart Association (NYHA) Classification | 0.12 Change in NYHA Class |
| Group B | New York Heart Association (NYHA) Classification | -0.10 Change in NYHA Class |
Other Pre-specified
Number and Percent of Participants With All-cause Hospitalizations.
Number and percent of participants who were hospitalized for any cause during follow-up.
Time frame: six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number and Percent of Participants With All-cause Hospitalizations. | 27 Participants |
| Group B | Number and Percent of Participants With All-cause Hospitalizations. | 25 Participants |
Other Pre-specified
Number and Percent of Participants With Worsening Heart Failure Events
Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management.
Time frame: six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number and Percent of Participants With Worsening Heart Failure Events | 10 Participants |
| Group B | Number and Percent of Participants With Worsening Heart Failure Events | 14 Participants |
Other Pre-specified
Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions
Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis.
Time frame: six months
Population: All patients with LVAD and CardioMEMS device in place.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | Driveline fracture (HM II) | 1 Participants |
| Group A | Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | No Device Malfunction (HM II & HM3) | 99 Participants |
| Group A | Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | Pump thrombosis (HM II) | 1 Participants |
Other Pre-specified
PA Diastolic Pressure Before 6MHW Test to After 6MHW Test
Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A | PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | 13.9 mmHg | Standard Deviation 7.2 |
| Group B | PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | 16.3 mmHg | Standard Deviation 6.8 |
| Group B Pre 6MHW Test | PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | 15.8 mmHg | Standard Deviation 8.2 |
| Group B Post 6MHW Test | PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | 19.8 mmHg | Standard Deviation 10.6 |