Heart Failure
Conditions
Keywords
implantable hemodynamic monitor, Intracardiac pressures
Brief summary
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.
Detailed description
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone. After baseline evaluation and verification that entrance criteria were met, all subjects were implanted with a Chronicle IHM and pressure sensor lead. Following successful implantation, subjects were randomized to either the CHRONICLE group or CONTROL group. Subjects randomized to the CHRONICLE group were managed using Chronicle, specifically trended RV and estimated PA pressure, heart rate and activity data, whereas subjects randomized to the CONTROL group were treated conventionally without the use of the Chronicle data. In the case that implantation was not successful, subjects were exited from the study if no procedure related adverse events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study. Subjects remained randomized until their six month clinic visit had been completed. Following the subject's six month visit, clinicians were granted access to the CONTROL subject's trended Chronicle data on the Chronicle website, and subjects were seen in the clinic for a protocol-required visit every six months until exit from the study.
Interventions
DEVICEChronicle Implantable Hemodynamic Monitor
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
OTHERStandard of Care
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV * Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation * Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
Exclusion criteria
* Subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation * Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted) * Subjects who are on continuous positive inotropic therapy * Subjects with known atrial or ventricular septal defects * Subjects with mechanical right heart valves * Subjects with stenotic tricuspid or pulmonary valves * Subjects with a presently implanted non-compatible pacemaker or ICD * Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months * Subjects with a major cardiovascular event within 3 months prior to baseline evaluation * Subjects with a severe non-cardiac condition limiting 6 month survival * Subjects with a primary diagnosis of pulmonary artery hypertension * Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis * Subjects enrolled in concurrent studies that may confound the results of this study * Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. | Within 6 months post-implant | A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months. |
| Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months. | Within 6 months post-implant | A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters. Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months. |
| Rate of Heart Failure-related Hospital Equivalents. | 6 Months post-implant | Hospital equivalents (HE) were defined to include the following events: 1. Heart failure-related hospital admissions for 24 hours or longer 2. Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). 3. Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire | 6 Months post-implant | Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life). Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis. |
| Health Care Utilization | 6 Months post-implant | Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits. |
| Distance Walked During a Six Minute Hall Walk | 6 Months post-implant | Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months. |
| New York Heart Association (NYHA) Class | 6 Months post-implant | New York Heart Association (NYHA) Classifications were defined as follows: Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Days Hospitalization Free | 6 Months post-implant | The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period. |
| Clinical Composite Response of Either Worsened, Improved, or Unchanged | 6 Months post-implant | Worsened, Improved and Unchanged were defined as follows: Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on March 13, 2003 and ended on November 16, 2004. All subjects were exited from the study on April 8, 2013. Twenty-nine US clinical centers participated in the COMPASS-HF study.
Pre-assignment details
Subjects were required to have a successful implant of the Chronicle® device prior to randomization. 277 subjects had an attempted implant, with 274 successfully implanted and randomized. 3 subjects had unsuccessful implant attempts and were exited prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Physicians have access to device-based hemodynamic monitor information to guide patient management | 134 |
| Control Physicians do not have access to device-based hemodynamic monitor information to guide patient management | 140 |
| Total | 274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 13 | 11 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Treatment |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 14 |
| New York Heart Association Class III (NYHA III) | 122 Participants | 234 Participants | 112 Participants |
| New York Heart Association Class IV (NYHA IV) | 18 Participants | 40 Participants | 22 Participants |
| Region of Enrollment United States | 140 participants | 274 participants | 134 participants |
| Sex: Female, Male Female | 50 Participants | 109 Participants | 59 Participants |
| Sex: Female, Male Male | 90 Participants | 165 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 134 | 11 / 140 |
| other Total, other adverse events | 15 / 134 | 17 / 140 |
| serious Total, serious adverse events | 79 / 134 | 91 / 140 |
Outcome results
Primary
Rate of Heart Failure-related Hospital Equivalents.
Hospital equivalents (HE) were defined to include the following events: 1. Heart failure-related hospital admissions for 24 hours or longer 2. Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). 3. Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).
Time frame: 6 Months post-implant
Population: All randomized subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Subjects With Attempted Implant | Rate of Heart Failure-related Hospital Equivalents. | 0.63 Events |
| Control | Rate of Heart Failure-related Hospital Equivalents. | 0.81 Events |
Primary
Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.
A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters. Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.
Time frame: Within 6 months post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects With Attempted Implant | Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months. | 274 Participants |
Primary
Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.
Time frame: Within 6 months post-implant
Population: The analysis population for safety includes all subjects with an attempted implant of the Chronicle implantable hemodynamic monitoring device, including both successful implanted participants (274) and unsuccessful implanted participants (3). In total 277 participants were assessed for the safety objective.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects With Attempted Implant | Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. | 277 Participants |
Secondary
Clinical Composite Response of Either Worsened, Improved, or Unchanged
Worsened, Improved and Unchanged were defined as follows: Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened.
Time frame: 6 Months post-implant
Population: All randomized subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects With Attempted Implant | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Improved | 56 Participants |
| All Subjects With Attempted Implant | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Worsend | 50 Participants |
| All Subjects With Attempted Implant | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Unchanged | 28 Participants |
| Control | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Improved | 48 Participants |
| Control | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Worsend | 66 Participants |
| Control | Clinical Composite Response of Either Worsened, Improved, or Unchanged | Unchanged | 26 Participants |
Secondary
Days Hospitalization Free
The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.
Time frame: 6 Months post-implant
Population: All randomized subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Subjects With Attempted Implant | Days Hospitalization Free | 170.8 Days |
| Control | Days Hospitalization Free | 172.7 Days |
Secondary
Distance Walked During a Six Minute Hall Walk
Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.
Time frame: 6 Months post-implant
Population: All randomized patients completing a hall walk at baseline and 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Subjects With Attempted Implant | Distance Walked During a Six Minute Hall Walk | 6.2 Meters | Standard Deviation 98.8 |
| Control | Distance Walked During a Six Minute Hall Walk | -8.2 Meters | Standard Deviation 114.2 |
Secondary
Health Care Utilization
Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
Time frame: 6 Months post-implant
Population: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects With Attempted Implant | Health Care Utilization | 218 Total number of events |
| Control | Health Care Utilization | 255 Total number of events |
Secondary
New York Heart Association (NYHA) Class
New York Heart Association (NYHA) Classifications were defined as follows: Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina. Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina. Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina. Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 6 Months post-implant
Population: All randomized subjects with NYHA assessment completed at baseline and at 6 months were included in the analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects With Attempted Implant | New York Heart Association (NYHA) Class | NYHA I | 7 Participants |
| All Subjects With Attempted Implant | New York Heart Association (NYHA) Class | NYHA III | 61 Participants |
| All Subjects With Attempted Implant | New York Heart Association (NYHA) Class | NYHA II | 39 Participants |
| All Subjects With Attempted Implant | New York Heart Association (NYHA) Class | NYHA IV | 6 Participants |
| Control | New York Heart Association (NYHA) Class | NYHA II | 31 Participants |
| Control | New York Heart Association (NYHA) Class | NYHA I | 11 Participants |
| Control | New York Heart Association (NYHA) Class | NYHA IV | 10 Participants |
| Control | New York Heart Association (NYHA) Class | NYHA III | 70 Participants |
Secondary
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life). Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis.
Time frame: 6 Months post-implant
Population: All randomized subjects completing a quality of life survey at the baseline visit and month 6 visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Subjects With Attempted Implant | Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire | -12.5 Index score |
| Control | Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire | -8.5 Index score |