Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

Study Overview
=================
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events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.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.

Official Title
-----------------
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Chronicle Implantable Hemodynamic Monitor
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHRONICLE<br>Subjects randomized to the CHRONICLE group were managed using data from an implantable hemodynamic monitoring (IHM) device, including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The Chronicle 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. | Device: Chronicle Implantable Hemodynamic Monitor<br>* 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.<br>|
| Placebo Comparator: CONTROL<br>Subjects randomized to the CONTROL group implanted with the Chronicle implantable hemodynamic monitoring (IHM) device, but the intracardiac diagnostic information was blinded to both the patient and the physician during the randomized period of the study. Subjects were managed conventionally with standard of care. Physicians and patients have access to the intracardiac data after the randomized period of the study is over, at 6 months. | Other: Standard of Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 6 months post-implant | 
| 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. | Within 6 months post-implant | 
| Rate of Heart Failure-related Hospital Equivalents. | Hospital equivalents (HE) were defined to include the following events: Heart failure-related hospital admissions for 24 hours or longer Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration). | 6 Months post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization | Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits. | 6 Months post-implant | 
| 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. | 6 Months post-implant | 
| 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. | 6 Months post-implant | 
| 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. | 6 Months post-implant | 
| 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. | 6 Months post-implant | 
| 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. | 6 Months post-implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implantable hemodynamic monitor, Intracardiac pressures