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

NCT00510198 | Terminated Results DMC

• 1 other identifier: 603
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Congestive Heart Failure

Keywords

Heart Disease; Congestive Heart Failure; Thoracic Fluid Monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations

  up to five years

• Cardiovascular Hospitalizations

  up to five years

Study Arms (2)

Control Arm 1: SOC and CC with OptiVol

ACTIVE COMPARATOR

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

Control Arm 2: SOC

ACTIVE COMPARATOR

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)

Interventions

Cardiac Compass with OptiVol Fluid Status Monitoring DEVICE

Review of Cardiac Compass with OptiVol Fluid Status Monitoring

Control Arm 1: SOC and CC with OptiVol

Standard of Care alone (clinical assessment) DEVICE

Clinical assessment utilizing standard of care, alone.

Control Arm 2: SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (33)

Unknown Facility

Anchorage, Alaska, 99508, United States

Location

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Little Rock, Arkansas, 72205, United States

Location

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Berkeley, California, 94705, United States

Location

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Larkspur, California, 94939, United States

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Colorado Springs, Colorado, 80909, United States

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Fort Collins, Colorado, 80528, United States

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Jacksonville, Florida, 32207, United States

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Atlanta, Georgia, 30306, United States

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Kankakee, Illinois, 60901, United States

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Oak Lawn, Illinois, 60453, United States

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Rockford, Illinois, 61107, United States

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Indianapolis, Indiana, 46260, United States

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Louisville, Kentucky, 40205, United States

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New Orleans, Louisiana, 70121, United States

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Takoma Park, Maryland, 20912, United States

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Springfield, Massachusetts, 01199, United States

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Saginaw, Michigan, 48601, United States

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Ypsilanti, Michigan, 48197, United States

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Saint Cloud, Minnesota, 56303, United States

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Saint Joseph, Missouri, 64501, United States

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St Louis, Missouri, 63110, United States

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Albany, New York, 12212, United States

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Akron, Ohio, 44304, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Elyria, Ohio, 44035, United States

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Oklahoma City, Oklahoma, 73120, United States

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Doylestown, Pennsylvania, 18901, United States

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Lancaster, Pennsylvania, 17603, United States

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Nashville, Tennessee, 37205, United States

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Austin, Texas, 78705, United States

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Richmond, Virginia, 23294, United States

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Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Limitations and Caveats

Because none of primary objectives of the study have been met, the pre-specified analyses for all secondary objectives were not performed (per study protocol).

Results Point of Contact

• Title: Clinical Trial leader
• Organization: Medtronic CRDM Clinical Research and Reimbursement

ming.duanmu@medtronic.com

7635262788

Study Officials

• PRECEDE-HF Study Team

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 10, 2019
• Results First Posted: April 10, 2019

Record last verified: 2019-03

Locations

US (33)