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Congestive Heart FailurePRECEDE-HFNCT00510198

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

A study testing Cardiac Compass with OptiVol Fluid Status Monitoring in people with Congestive Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 33 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Cardiac Compass with OptiVol Fluid Status Monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
33 sitesUnited States
Study dates
Oct 2007to Apr 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Study site

    Akron, Ohio, 44304

  • Study site

    Albany, New York, 12212

  • Study site

    Anchorage, Alaska, 99508

  • Study site

    Atlanta, Georgia, 30306

  • Study site

    Austin, Texas, 78705

  • Study site

    Berkeley, California, 94705

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Elyria, Ohio, 44035

  • Study site

    Fort Collins, Colorado, 80528

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Jacksonville, Florida, 32207

  • Study site

    Kankakee, Illinois, 60901

  • Study site

    Lancaster, Pennsylvania, 17603

  • Study site

    Larkspur, California, 94939

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Louisville, Kentucky, 40205

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    Oak Lawn, Illinois, 60453

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rockford, Illinois, 61107

  • Study site

    Saginaw, Michigan, 48601

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    Saint Joseph, Missouri, 64501

  • Study site

    Springfield, Massachusetts, 01199

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Takoma Park, Maryland, 20912

  • Study site

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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.

Read the 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)
Being tested
Cardiac Compass with OptiVol Fluid Status Monitoring, Standard of Care alone (clinical assessment)
Keywords
Heart Disease, Congestive Heart Failure, Thoracic Fluid Monitoring
Medical subject headings
Heart Failure, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Compass with OptiVol Fluid Status MonitoringDevice

    Review of Cardiac Compass with OptiVol Fluid Status Monitoring

  • Standard of Care alone (clinical assessment)Device

    Clinical assessment utilizing standard of care, alone.

Study groups in NCT00510198
Study groupRoleWhat they receive
Control Arm 1: SOC and CC with OptiVolActive comparatorStandard 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.
Receives: Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Control Arm 2: SOCActive comparatorIntervention is Standard of Care alone, such as assessment of symptoms, only. Device trending information, but OptiVol is not allowed.
Receives: Device: Standard of Care alone (clinical assessment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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")

    Measured: Up to five years

  2. 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

    Measured: Up to five years

Secondary outcomes (2)

  1. 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

    Measured: up to five years

  2. Cardiovascular Hospitalizations

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

    Measured: up to five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Why it stopped: Study enrollment significantly below protocol expectation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00510198
Sponsor's protocol ID
603
Acronym
PRECEDE-HF
Status last verified
Mar 2019
First submitted
31 Jul 2007
Last updated
10 Apr 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Compass with OptiVol Fluid Status Monitoring in people with Congestive Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Heart-Failure Hospitalization or All-Cause Death (time frame: Up to five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00510198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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