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Heart FailurePhase 4NCT00847288

OptiVol® Care Pathway

A Phase 4 study testing Monthly Review Arm and Quarterly Review Arm in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 108 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States. The purpose of this clinical trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Monthly Review Arm and Quarterly Review Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,682 participants
Where
108 sitesUnited States
Study dates
Mar 2009to May 2011
Phase
Phase 4
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

  • Subject (or subject's legally authorized representative) is willing and able to sign and date written consent form and Authorization for Access to and Use of Health Information
  • Subject is at least 18 years of age
  • Subject is willing and able to comply with Clinical Investigation Plan
  • Subject is willing and able to transmit data using Medtronic CareLink® Network
  • Subject has market released right atrial (RA) (if applicable), right ventricular (RV), and left ventricular (LV) (if applicable) leads and one of the following generators implanted: Concerto® CRT-D - Model C154DWK, Virtuoso® DR ICD - Model D154AWG, Virtuoso® VR ICD - Model D154VWC, Consulta™ CRT-D - Model D224TRK, Secura™ DR ICD - Model D224DRG, Secura™ VR ICD - Model D224VRC, or any future market released Medtronic generator with wireless telemetry, Cardiac Compass with OptiVol Fluid Status Monitoring, and that is supported by the Medtronic CareLink Network

Who cannot join

  • Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
  • Subject has life expectancy of less than 1 year

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

United States108 sites

  • Study site

    Akron, Ohio

  • Study site

    Alhambra, California

  • Study site

    Anchorage, Alaska

  • Study site

    Ashland, Kentucky

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Bangor, Maine

  • Study site

    Bend, Oregon

  • Study site

    Berkeley, California

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomington, Indiana

  • Study site

    Boston, Massachusetts

  • Study site

    Boulder, Colorado

  • Study site

    Brandenton, Florida

  • Study site

    Bridgewater, New Jersey

  • Study site

    Buffalo, New York

  • Study site

    Burbank, California

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Coon Rapids, Minnesota

  • Study site

    Corpus Christi, Texas

  • Study site

    Davenport, Iowa

  • Study site

    Daytona Beach, Florida

  • Study site

    Des Moines, Iowa

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Fayetteville, New York

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Smith, Arkansas

  • Study site

    Gainesville, Florida

  • Study site

    Galloway, New Jersey

  • Study site

    Garden City, New York, 11530

  • Study site

    Gastonia, North Carolina

  • Study site

    Germantown, Tennessee

  • Study site

    Glen Burnie, Maryland

  • Study site

    Grand Blanc, Michigan

  • Study site

    Grand Rapids, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenwood, South Carolina

  • Study site

    Inverness, Florida

  • Study site

    Jacksonville, Florida

  • Study site

    Johnson City, Tennessee

  • Study site

    Jupiter, Florida

  • Study site

    Kankakee, Illinois

  • Study site

    Kansas City, Missouri

  • Study site

    Kettering, Ohio

  • Study site

    La Jolla, California

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Larkspur, California

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Louisville, Kentucky

  • Study site

    Lynchburg, Virginia

  • Study site

    Madison, Wisconsin

  • Study site

    McAllen, Texas

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Mesa, Arizona

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Minot, North Dakota

  • Study site

    Mobile, Alabama

  • Study site

    Muncie, Indiana

  • Study site

    Munster, Indiana

  • Study site

    Nashville, Tennessee

  • Study site

    Newark, New Jersey, 07105

  • Study site

    Oak Lawn, Illinois

  • Study site

    Ocean City, New Jersey, 07712

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Petosky, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Poland, Ohio, 44514

  • Study site

    Pomona, California, 91767

  • Study site

    Rancho Mirage, California

  • Study site

    Reno, Nevada

  • Study site

    Riverside, California

  • Study site

    Rockford, Illinois

  • Study site

    Rockville, Maryland

  • Study site

    Saint Cloud, Minnesota

  • Study site

    Saint Joseph, Missouri

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California, 94115

  • Study site

    Shreveport, Louisiana

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Missouri

  • Study site

    St Louis, Missouri

  • Study site

    Sterling Heights, Michigan

  • Study site

    Steubenville, Ohio

  • Study site

    Terre Haute, Indiana

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Trinity, Florida

  • Study site

    Tyler, Texas

  • Study site

    Voorhees Township, New Jersey

  • Study site

    West Columbia, South Carolina

  • Study site

    Wilmington, North Carolina

  • Study site

    Wynnewood, Pennsylvania

Other trials in United States

About this study

Medtronic, Inc. is sponsoring the OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States. The purpose of this clinical trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. It is hypothesized that monthly review of Cardiac Compass Trends with OptiVol will shorten time to clinical action as compared to quarterly review.

Conditions
Heart Failure
Being tested
Monthly Review Arm, Quarterly Review Arm
Keywords
Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy with Defibrillator (CRT D), OptiVol®
Medical subject headings
Heart Failure

What participants receive

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

  • Monthly Review ArmOther

    Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

  • Quarterly Review ArmOther

    Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

Study groups in NCT00847288
Study groupRoleWhat they receive
Monthly Review ArmExperimentalPatients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Receives: Other: Monthly Review Arm
Quarterly Review ArmActive comparatorPatients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Receives: Other: Quarterly Review Arm

What is being measured

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

  1. Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol

    Measured: 1 year

Secondary outcomes (3)

  1. Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm

    There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.

    Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score.

    Measured: 1 year

  2. Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews

    The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.

    Measured: 1 year

  3. Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol

    Measured: 1 year

Timeline

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

  1. First posted19 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2011
  4. Study completionMay 2011

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00847288
Sponsor's protocol ID
OptiVol® Care Pathway
Status last verified
Apr 2013
First submitted
13 Feb 2009
Last updated
3 May 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Monthly Review Arm and Quarterly Review Arm in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 108 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2013). 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?

Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol (time frame: 1 year). 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 NCT00847288.

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 3 May 2013.

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OptiVol® Care Pathway (NCT00847288) | AzTrials