Heart FailureNCT00643279
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
A study testing Chronicle Implantable Hemodynamic Monitor in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 28 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Chronicle Implantable Hemodynamic Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 28 sitesUnited States
- Study dates
- Mar 2003to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Crawford LongHospital
Atlanta, Georgia
University of Alabama at Birmingham
Birmingham, Alabama
New England Medical Center
Boston, Massachusetts
Duke University
Chapel Hill, North Carolina
Medical University of South Carolina
Charleston, South Carolina
University of Cincinnati
Cincinnati, Ohio
The Ohio State University
Columbus, Ohio
Parkview Memorial Hospital
Fort Wayne, Indiana
University of Florida - Shands
Gainesville, Florida
Baptist Memorial Hospital
Germantown, Tennessee
St. Luke's Episcopal Hospital/Texas Heart
Houston, Texas
Mid America Heart Institute
Kansas City, Missouri
Loma Linda University Medical Center
Loma Linda, California
UCLA Medical Center
Los Angeles, California
University of Southern California
Los Angeles, California
St. Thomas Hospital
Nashville, Tennessee
Robert Wood Johnson Medical Center
New Brunswick, New Jersey
New York Presbyterian - Columbia
New York, New York
Newark Beth Israel
Newark, New Jersey
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania
St. Paul Heart
Saint Paul, Minnesota
LDS Hospital
Salt Lake City, Utah
University of Washington Medical Center
Seattle, Washington
Prairie Heart Institute
Springfield, Illinois
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Keywords
- implantable hemodynamic monitor, Intracardiac pressures
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronicle Implantable Hemodynamic MonitorDevice
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CHRONICLE | Experimental | 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. Receives: Device: Chronicle Implantable Hemodynamic Monitor |
| CONTROL | Placebo comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 6 Months post-implant
Secondary outcomes (6)
Health Care Utilization
Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2003
- Primary completionJun 2005
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bourge, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643279
- Sponsor's protocol ID
- COMPASS-HF
- Status last verified
- Dec 2023
- First submitted
- 29 Feb 2008
- Last updated
- 22 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21440865
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
- ClinicalTrials.gov ID
- NCT00643279
- Acronym / sponsor ID
- COMPASS-HF
- Conditions
- Heart Failure
- Keywords
- implantable hemodynamic monitor, Intracardiac pressures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHRONICLE | Experimental | Device: Chronicle Implantable Hemodynamic MonitorSubjects 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. |
| CONTROL | Placebo comparator | Other: Standard of CareSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronicle Implantable Hemodynamic MonitorSurgical 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. | Device | CHRONICLE |
| Standard of CareSurgical 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. | Other | CONTROL |
Primary outcome
Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
Time frame: 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.
Time frame: 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.
Time frame: 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).
6 secondary outcomes
Health Care Utilization
Time frame: 6 Months post-implant
Days Hospitalization Free
Time frame: 6 Months post-implant
Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"
Time frame: 6 Months post-implant
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
Time frame: 6 Months post-implant
New York Heart Association (NYHA) Class
Time frame: 6 Months post-implant
Distance Walked During a Six Minute Hall Walk
Time frame: 6 Months post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21440865Zile 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bourge, MD principal investigator
The University of Alabama at Birmingham
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronicle Implantable Hemodynamic Monitor in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. (time frame: Within 6 months post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.