Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure (PRECEDE-HF)

March 18, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Berkeley, California, United States, 94705
      • Larkspur, California, United States, 94939
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
      • Fort Collins, Colorado, United States, 80528
    • Florida
      • Jacksonville, Florida, United States, 32207
    • Georgia
      • Atlanta, Georgia, United States, 30306
    • Illinois
      • Kankakee, Illinois, United States, 60901
      • Oak Lawn, Illinois, United States, 60453
      • Rockford, Illinois, United States, 61107
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Louisville, Kentucky, United States, 40205
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Takoma Park, Maryland, United States, 20912
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
    • Michigan
      • Saginaw, Michigan, United States, 48601
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
    • Missouri
      • Saint Joseph, Missouri, United States, 64501
      • Saint Louis, Missouri, United States, 63110
    • New York
      • Albany, New York, United States, 12212
    • Ohio
      • Akron, Ohio, United States, 44304
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
      • Elyria, Ohio, United States, 44035
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
      • Lancaster, Pennsylvania, United States, 17603
    • Tennessee
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Austin, Texas, United States, 78705
    • Virginia
      • Richmond, Virginia, United States, 23294
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional 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
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
Review of Cardiac Compass with OptiVol Fluid Status Monitoring
Active Comparator: Control Arm 2: SOC
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)
Clinical assessment utilizing standard of care, alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Heart-Failure Hospitalization or All-Cause Death
Time Frame: Up to five years
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
Time Frame: Up to five years
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
Time Frame: up to five years
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
Time Frame: up to five years
To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm
up to five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: PRECEDE-HF Study Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (Estimate)

August 1, 2007

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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