Trial Outcomes & Findings for Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure (NCT NCT00510198)

Last Updated: 2019-04-10

Results Overview

A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring ("Access Arm") compared to HF subjects managed with standard clinical assessment alone ("Control Arm")

Recruitment status

TERMINATED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Up to five years

Results posted on

2019-04-10

Participant Flow

120 subjects were enrolled but 3 were not randomized into the study for not meeting the inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	Access Arm Standard of Care and Cardiac Compass with OptiVol	Control Arm Standard of Care alone
Overall Study STARTED	59	58
Overall Study COMPLETED	54	54
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Access Arm Standard of Care and Cardiac Compass with OptiVol	Control Arm Standard of Care alone
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Access Arm n=59 Participants Standard of Care and Cardiac Compass with OptiVol	Control Arm n=58 Participants Standard of Care alone	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Age, Continuous	65.5 years STANDARD_DEVIATION 17.3 • n=5 Participants	63.8 years STANDARD_DEVIATION 15.1 • n=7 Participants	64.7 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	23 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	35 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	58 participants n=7 Participants	117 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to five years

Population: all randomized subjects; intention to treat

Outcome measures

Outcome measures
Measure	Access Arm n=59 Participants Standard of Care and Cardiac Compass with OptiVol	Control Arm n=58 Participants Standard of Care alone
Number of Participants With Heart-Failure Hospitalization or All-Cause Death	14 Participants with an Event	9 Participants with an Event

PRIMARY outcome

Timeframe: Up to five years

Population: all randomized subjects; intention to treat

A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death

Outcome measures

Outcome measures
Measure	Access Arm n=59 Participants Standard of Care and Cardiac Compass with OptiVol	Control Arm n=58 Participants Standard of Care alone
Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm	16 Number of Participants with a Event	13 Number of Participants with a Event

SECONDARY outcome

Timeframe: up to five years

Population: Study was stopped early, therefore secondary objectives were not analyzed.

To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to five years

Population: The study was stopped early, therefore secondary objectives were not able to be analyzed.

To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm

Outcome measures

Outcome data not reported

Adverse Events

Access Arm

Serious events: 32 serious events

Other events: 11 other events

Deaths: 0 deaths

Control Arm

Serious events: 21 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Access Arm n=59 participants at risk Standard of Care and Cardiac Compass with OptiVol	Control Arm n=58 participants at risk Standard of Care alone
Cardiac disorders ACUTE DECOMPENSATED HEART FAILURE	6.8% 4/59 • Number of events 4 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.	0.00% 0/58 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.
Psychiatric disorders ANXIETY	5.1% 3/59 • Number of events 3 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.	1.7% 1/58 • Number of events 1 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.
Immune system disorders GOUT	6.8% 4/59 • Number of events 6 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.	3.4% 2/58 • Number of events 2 • up to five years Definition of Serious AE: Any significant adverse experience, including those which may be either life threatening or involve permanent or long term injuries, but excluding injuries that are non-life threatening and that are temporary and reasonably reversible.

Additional Information

Clinical Trial leader

Medtronic CRDM Clinical Research and Reimbursement

Phone: 7635262788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place