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

Study Overview
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Brief Summary
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The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease) combined with standard treatment methods (Access Group) to patients whose heart failure is managed by standard treatment methods only (Control Group). This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death.

Detailed Description
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PRECEDE-HF was a prospective, multi-center, randomized, investigational device exemption (IDE) clinical study. The purpose of this study was to collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment (Access Arm) will result in a longer time to first heart failure hospitalization or death compared to standard clinical assessment alone (Control Arm) and to support the approval of the following device features: OptiVol Alert (audible and home monitor alerts) for use in Medtronic devices SentryCheck™ Monitor OptiVol Alert Suspend (OptiVol enhancement) OptiVol Reference Impedance Adjustment (OptiVol enhancement)

Official Title
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PRECEDE-HF -Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Device: Cardiac Compass with OptiVol Fluid Status Monitoring
* Device: Standard of Care alone (clinical assessment)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria The following criteria apply to all subjects: Subject has a CRT-D or dual chamber ICD with Cardiac Compass and OptiVol Fluid Status Monitoring implanted in the pectoral region at least 30 days prior to enrollment. CRT-D/ICD must be supported by the Medtronic CareLink Network. Subject has a market-released, transvenous, high voltage RV lead Subject has a market-released RA lead If subject has an LV lead, it must be compatible, not Y-adapted and not currently under investigation Subject's heart failure regimen (i.e. beta blocker and ACE inhibitor (or substitute) unless documented evidence of intolerance is available) adheres to current ACC/AHA guidelines for management of chronic heart failure in adult patients Subject has a history of at least one heart failure related hospitalization, Emergency Department (ED) visit, or urgent visit necessitating IV diuretic, IV inotropic, IV vasodilator, or other parenteral therapy within 12 months prior to baseline evaluation Subject is at least 18 years of age Subject is willing and able to comply with the Clinical Investigation Plan (e.g. willing and able to remain available for follow-up visits, use SentryCheck, etc.) Subject is willing and able to transmit data using the Medtronic CareLink Network Subject (or subject's legally authorized representative) is willing and able to sign and date the study Informed Consent and HIPAA Authorization (U.S.) Exclusion Criteria The following criteria apply to all subjects: Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year Subject received a coronary artery bypass graft or valve surgery in the last 90 days Subject had a myocardial infarction (MI) in the last 90 days. Subject is indicated for valve replacement/repair Subject's life expectancy due to non-cardiac reasons is less than six months Subject has serum creatinine > 2.5 mg/dL measured within 30 days prior to enrollment. Subject is on chronic renal dialysis Subject is on continuous or intermittent (> 2 stable infusions per week) infusion therapy for HF Subject has complex and uncorrected congenital heart disease Subject is enrolled in a Disease Management Program where an outside vendor, company or service is employed to determine, monitor, and/ or alert a clinician or subject to weight changes or other HF signs or symptoms via interactive or passive systems Subject is implanted with a cardiac hemodynamic monitor or left ventricular assist device(LVAD) Subject is enrolled in a concurrent study, with the exception of a study approved by the Medtronic PRECEDE-HF Clinical Trial Leader prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm 1: SOC and CC with OptiVol<br>Standard of Care and Cardiac Compass with OptiVol as the Control. Intervention is standard of care, such as symptom assessment with the addition of viewing Cardiac Compass trends and the OptiVol diagnostic. | Device: Cardiac Compass with OptiVol Fluid Status Monitoring<br>* Review of Cardiac Compass with OptiVol Fluid Status Monitoring<br>|
| Active Comparator: Control Arm 2: SOC<br>Intervention is Standard of Care alone, such as assessment of symptoms, only. Device trending information, but OptiVol is not allowed. | Device: Standard of Care alone (clinical assessment)<br>* Clinical assessment utilizing standard of care, alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Heart-Failure Hospitalization or All-Cause Death | 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) | Up to five years | 
| 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 | 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 | Up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations | To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm | up to five years | 
| Cardiovascular Hospitalizations | To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm | up to five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Disease, Congestive Heart Failure, Thoracic Fluid Monitoring