Trial Outcomes & Findings for Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) (NCT NCT00643279)

NCT ID: NCT00643279

Last Updated: 2023-12-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 277 participants
• Primary outcome timeframe: Within 6 months post-implant
• Results posted on: 2023-12-22

Participant Flow

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.

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.

Participant milestones

Measure	Treatment Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Overall Study STARTED	134	140
Overall Study COMPLETED	118	127
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Measure	Treatment Physicians have access to device-based hemodynamic monitor information to guide patient management	Control Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Overall Study Death	13	11
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=134 Participants Physicians have access to device-based hemodynamic monitor information to guide patient management	Control n=140 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management	Total n=274 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 14 • n=5 Participants	58 years STANDARD_DEVIATION 13 • n=7 Participants	58 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	50 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	90 Participants n=7 Participants	165 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants	140 participants n=7 Participants	274 participants n=5 Participants
New York Heart Association Class III (NYHA III)	112 Participants n=5 Participants	122 Participants n=7 Participants	234 Participants n=5 Participants
New York Heart Association Class IV (NYHA IV)	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	All Subjects With Attempted Implant n=277 Participants All subjects with an attempted implant of a Chronicle IHM.	Control Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.	277 Participants	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Subjects With Attempted Implant n=274 Participants All subjects with an attempted implant of a Chronicle IHM.	Control Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.	274 Participants	—

PRIMARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects

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).

Outcome measures

Measure	All Subjects With Attempted Implant n=134 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=140 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Rate of Heart Failure-related Hospital Equivalents.	0.63 Events Interval 0.51 to 0.78	0.81 Events Interval 0.67 to 0.97

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects

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

Outcome measures

Measure	All Subjects With Attempted Implant n=134 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=140 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Health Care Utilization	218 Total number of events	255 Total number of events

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects

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.

Outcome measures

Measure	All Subjects With Attempted Implant n=134 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=140 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Days Hospitalization Free	170.8 Days Interval 164.1 to 177.6	172.7 Days Interval 166.6 to 178.9

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects

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.

Outcome measures

Measure	All Subjects With Attempted Implant n=134 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=140 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged" Improved	56 Participants	48 Participants
Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged" Worsend	50 Participants	66 Participants
Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged" Unchanged	28 Participants	26 Participants

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects completing a quality of life survey at the baseline visit and month 6 visit

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.

Outcome measures

Measure	All Subjects With Attempted Implant n=117 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=127 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire	-12.5 Index score Interval -69.0 to 42.0	-8.5 Index score Interval -73.0 to 89.0

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized subjects with NYHA assessment completed at baseline and at 6 months were included in the analysis

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.

Outcome measures

Measure	All Subjects With Attempted Implant n=113 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=122 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
New York Heart Association (NYHA) Class NYHA I	7 Participants	11 Participants
New York Heart Association (NYHA) Class NYHA II	39 Participants	31 Participants
New York Heart Association (NYHA) Class NYHA III	61 Participants	70 Participants
New York Heart Association (NYHA) Class NYHA IV	6 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 Months post-implant

Population: All randomized patients completing a hall walk at baseline and 6 months.

Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.

Outcome measures

Measure	All Subjects With Attempted Implant n=112 Participants All subjects with an attempted implant of a Chronicle IHM.	Control n=115 Participants Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Distance Walked During a Six Minute Hall Walk	6.2 Meters Standard Deviation 98.8	-8.2 Meters Standard Deviation 114.2

Adverse Events

Treatment

Serious events: 79 serious events

Other events: 15 other events

Deaths: 13 deaths

Control

Serious events: 91 serious events

Other events: 17 other events

Deaths: 11 deaths

Serious adverse events

Measure	Treatment n=134 participants at risk Physicians have access to device-based hemodynamic monitor information to guide patient management	Control n=140 participants at risk Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Cardiac disorders Decompensation of heart failure	26.1% 35/134 • Number of events 57 • 6 months	30.7% 43/140 • Number of events 68 • 6 months
Cardiac disorders Volume overload	4.5% 6/134 • Number of events 10 • 6 months	11.4% 16/140 • Number of events 26 • 6 months
Cardiac disorders Volume depletion/dehydration	4.5% 6/134 • Number of events 6 • 6 months	3.6% 5/140 • Number of events 6 • 6 months
Cardiac disorders Angina pectoris	6.0% 8/134 • Number of events 8 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Cardiovascular procedure	3.0% 4/134 • Number of events 4 • 6 months	3.6% 5/140 • Number of events 6 • 6 months
Cardiac disorders Hypotension	0.75% 1/134 • Number of events 1 • 6 months	2.9% 4/140 • Number of events 4 • 6 months
Cardiac disorders Non-specific chest	2.2% 3/134 • Number of events 4 • 6 months	2.9% 4/140 • Number of events 4 • 6 months
Cardiac disorders Non sustained VT	0.75% 1/134 • Number of events 1 • 6 months	2.1% 3/140 • Number of events 3 • 6 months
Cardiac disorders Sustained VT	0.75% 1/134 • Number of events 1 • 6 months	2.1% 3/140 • Number of events 3 • 6 months
Cardiac disorders Acute MI/Cardiac Arrest	2.2% 3/134 • Number of events 3 • 6 months	2.1% 3/140 • Number of events 3 • 6 months
Cardiac disorders Atrial tachycardia	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Paroxysmal atrial flutter/fibrillation	2.2% 3/134 • Number of events 4 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Persistent atrial flutter/fibrillation	0.75% 1/134 • Number of events 1 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Ventricular fibrillation/flutter	1.5% 2/134 • Number of events 2 • 6 months	1.4% 2/140 • Number of events 2 • 6 months
Cardiac disorders Hypertension	0.75% 1/134 • Number of events 1 • 6 months	1.4% 2/140 • Number of events 2 • 6 months
Renal and urinary disorders Renal insufficiencies/failure	1.5% 2/134 • Number of events 2 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumonia	0.75% 1/134 • Number of events 1 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Gastrointestinal disorders Ascites	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Nervous system disorders Stroke	0.75% 1/134 • Number of events 1 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Electro Mechanical Dis-association	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Endocrine disorders Hyponatremia	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Endocrine disorders Hypokalemia	0.00% 0/134 • 6 months	1.4% 2/140 • Number of events 2 • 6 months
Surgical and medical procedures Elective Surgery	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Inhalant Poisoning from Cleaning Agents	0.00% 0/134 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Sudden Cardiac Death	0.75% 1/134 • Number of events 1 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea/SOB	1.5% 2/134 • Number of events 2 • 6 months	0.00% 0/140 • 6 months
Cardiac disorders Edema/weight gain	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Blood and lymphatic system disorders Lab value abnormalities	2.2% 3/134 • Number of events 3 • 6 months	0.00% 0/140 • 6 months
Respiratory, thoracic and mediastinal disorders Worsening COPD	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Blood and lymphatic system disorders Anemia	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
General disorders Urinary Tract Infection	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Psychiatric disorders Change in mental status	0.75% 1/134 • Number of events 2 • 6 months	0.00% 0/140 • 6 months
Respiratory, thoracic and mediastinal disorders Respiratory Failure/Arrest	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Infections and infestations MRSA Infection	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Infections and infestations Sepsis	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Cardiac disorders Cardiac Transplant	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Vascular disorders Peripheral Vascular Disease	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
General disorders Allergic Reaction	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months
Cardiac disorders Coronary Artery	0.75% 1/134 • Number of events 1 • 6 months	0.00% 0/140 • 6 months

Other adverse events

Measure	Treatment n=134 participants at risk Physicians have access to device-based hemodynamic monitor information to guide patient management	Control n=140 participants at risk Physicians do not have access to device-based hemodynamic monitor information to guide patient management
Cardiac disorders Sustained VT	0.00% 0/134 • 6 months	1.4% 2/140 • Number of events 2 • 6 months
Cardiac disorders Hypotension	1.5% 2/134 • Number of events 2 • 6 months	0.00% 0/140 • 6 months
Cardiac disorders Decompensated Heart Failure	3.7% 5/134 • Number of events 6 • 6 months	3.6% 5/140 • Number of events 5 • 6 months
Cardiac disorders Angina	1.5% 2/134 • Number of events 3 • 6 months	0.71% 1/140 • Number of events 1 • 6 months
Cardiac disorders Volume depletion/dehydration	1.5% 2/134 • Number of events 2 • 6 months	2.1% 3/140 • Number of events 3 • 6 months
Cardiac disorders Volume overload	3.0% 4/134 • Number of events 4 • 6 months	4.3% 6/140 • Number of events 10 • 6 months

Additional Information

Dana Wigert

Medtronic

Phone: 763-526-2802

Email: dana.wigert@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place