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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronicle Implantable Hemodynamic Monitor
Standard of Care
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring implantable hemodynamic monitor, Intracardiac pressures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Loma Linda University Medical Center
  • UCLA Medical Center
  • University of Southern California
  • University of Florida - Shands
  • Crawford LongHospital
  • Prairie Heart Institute
  • Parkview Memorial Hospital
  • New England Medical Center
  • St. Paul Heart
  • Mid America Heart Institute
  • Robert Wood Johnson Medical Center
  • Newark Beth Israel
  • New York Presbyterian - Columbia
  • Duke University
  • University of Cincinnati
  • The Ohio State University
  • Oklahoma Cardiovascular Associates
  • University of Oklahoma
  • Hospital of the University of Pennsylvania
  • Temple University Hospital
  • University of Pittsburgh
  • Medical University of South Carolina
  • Baptist Memorial Hospital
  • St. Thomas Hospital
  • St. Luke's Episcopal Hospital/Texas Heart
  • LDS Hospital
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHRONICLE

CONTROL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Health Care Utilization
Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
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.
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.
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.
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.
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.

Full Information

First Posted
February 29, 2008
Last Updated
August 13, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00643279
Brief Title
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Official Title
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
implantable hemodynamic monitor, Intracardiac pressures

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHRONICLE
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Chronicle Implantable Hemodynamic Monitor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
Description
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
Title
Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.
Description
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
Title
Rate of Heart Failure-related Hospital Equivalents.
Description
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).
Time Frame
6 Months post-implant
Secondary Outcome Measure Information:
Title
Health Care Utilization
Description
Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
Time Frame
6 Months post-implant
Title
Days Hospitalization Free
Description
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
Title
Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"
Description
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
Title
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
Description
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
Title
New York Heart Association (NYHA) Class
Description
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
Title
Distance Walked During a Six Minute Hall Walk
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bourge, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of Florida - Shands
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Crawford LongHospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Prairie Heart Institute
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
Parkview Memorial Hospital
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
New England Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
St. Paul Heart
City
Saint Paul
State/Province
Minnesota
Country
United States
Facility Name
Mid America Heart Institute
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Robert Wood Johnson Medical Center
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Newark Beth Israel
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
New York Presbyterian - Columbia
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oklahoma Cardiovascular Associates
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Baptist Memorial Hospital
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
St. Luke's Episcopal Hospital/Texas Heart
City
Houston
State/Province
Texas
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21440865
Citation
Zile MR, Adamson PB, Cho YK, Bennett TD, Bourge RC, Aaron MF, Aranda JM Jr, Abraham WT, Stevenson LW, Kueffer FJ. Hemodynamic factors associated with acute decompensated heart failure: part 1--insights into pathophysiology. J Card Fail. 2011 Apr;17(4):282-91. doi: 10.1016/j.cardfail.2011.01.010. Epub 2011 Feb 26.
Results Reference
derived

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

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