OptiVol® Care Pathway

April 30, 2013 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1682

Phase

  • Phase 4

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
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Mesa, Arizona, United States
    • Arkansas
      • Ft. Smith, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Alhambra, California, United States
      • Berkeley, California, United States
      • Burbank, California, United States
      • Chula Vista, California, United States
      • La Jolla, California, United States
      • Larkspur, California, United States
      • Pomona, California, United States, 91767
      • Rancho Mirage, California, United States
      • Riverside, California, United States
      • San Francisco, California, United States, 94115
      • Torrance, California, United States
    • Colorado
      • Boulder, Colorado, United States
      • Colorado Springs, Colorado, United States
    • Florida
      • Brandenton, Florida, United States
      • Clearwater, Florida, United States
      • Daytona Beach, Florida, United States
      • Ft. Lauderdale, Florida, United States
      • Gainesville, Florida, United States
      • Inverness, Florida, United States
      • Jacksonville, Florida, United States
      • Jupiter, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Trinity, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Columbus, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Kankakee, Illinois, United States
      • Oak Lawn, Illinois, United States
      • Rockford, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Muncie, Indiana, United States
      • Munster, Indiana, United States
      • Terre Haute, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
      • Des Moines, Iowa, United States
    • Kentucky
      • Ashland, Kentucky, United States
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maine
      • Bangor, Maine, United States
    • Maryland
      • Glen Burnie, Maryland, United States
      • Rockville, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States, 48236
      • Grand Blanc, Michigan, United States
      • Grand Rapids, Michigan, United States
      • Petosky, Michigan, United States
      • Sterling Heights, Michigan, United States
    • Minnesota
      • Coon Rapids, Minnesota, United States
      • Minneapolis, Minnesota, United States
      • St. Cloud, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
      • Springfield, Missouri, United States
      • St. Joseph, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Reno, Nevada, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Galloway, New Jersey, United States
      • Newark, New Jersey, United States, 07105
      • Ocean, New Jersey, United States, 07712
      • Voorhees, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • Fayetteville, New York, United States
      • Garden City, New York, United States, 11530
    • North Carolina
      • Durham, North Carolina, United States
      • Gastonia, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Wilmington, North Carolina, United States
    • North Dakota
      • Minot, North Dakota, United States
    • Ohio
      • Akron, Ohio, United States
      • Cleveland, Ohio, United States
      • Kettering, Ohio, United States
      • Poland, Ohio, United States, 44514
      • Steubenville, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
      • Greenwood, South Carolina, United States
      • Spartanburg, South Carolina, United States
      • West Columbia, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Johnson City, Tennessee, United States
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Corpus Christi, Texas, United States
      • McAllen, Texas, United States
      • San Antonio, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Lynchburg, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Other: Monthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Active Comparator: Quarterly Review Arm
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Other: Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Time Frame: 1 year

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.
1 year
Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews
Time Frame: 1 year
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.
1 year
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
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Wilson Tang, MD, Department of Cardiovascular Medicine, Cleveland Clinic

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

March 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 3, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OptiVol® Care Pathway

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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