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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1682

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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