OptiVol® Care Pathway

NCT00847288 | Completed Phase 4 Results

• 1 other identifier: OptiVol® Care Pathway
• Study Type: interventional
• Target: 1,682
• Locations: 1 country
• Sites: 108

Brief 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. 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

Keywords

Heart Failure; Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy with Defibrillator (CRT D); OptiVol®

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (3)

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

  1 year

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

  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

  1 year

Study Arms (2)

Monthly Review Arm

EXPERIMENTAL

Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly

Other: Monthly Review Arm

Quarterly Review Arm

ACTIVE COMPARATOR

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

Interventions

Monthly Review Arm OTHER

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

Monthly Review Arm

Quarterly Review Arm OTHER

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

Quarterly Review Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (108)

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Mesa, Arizona, United States

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Fort Smith, Arkansas, United States

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Little Rock, Arkansas, United States

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Alhambra, California, United States

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Berkeley, California, United States

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Burbank, California, United States

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Chula Vista, California, United States

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La Jolla, California, United States

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Larkspur, California, United States

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Pomona, California, 91767, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

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San Francisco, California, 94115, United States

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Torrance, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Brandenton, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Trinity, Florida, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Chicago, Illinois, United States

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Kankakee, Illinois, United States

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Oak Lawn, Illinois, United States

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Rockford, Illinois, United States

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Bloomington, Indiana, United States

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Muncie, Indiana, United States

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Munster, Indiana, United States

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Terre Haute, Indiana, United States

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Davenport, Iowa, United States

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Des Moines, Iowa, United States

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Ashland, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Glen Burnie, Maryland, United States

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Rockville, Maryland, United States

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Salisbury, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, 48236, United States

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Grand Blanc, Michigan, United States

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Grand Rapids, Michigan, United States

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Petosky, Michigan, United States

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Sterling Heights, Michigan, United States

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Coon Rapids, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Saint Joseph, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Bridgewater, New Jersey, United States

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Galloway, New Jersey, United States

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Newark, New Jersey, 07105, United States

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Ocean City, New Jersey, 07712, United States

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Voorhees Township, New Jersey, United States

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Buffalo, New York, United States

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Fayetteville, New York, United States

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Garden City, New York, 11530, United States

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Durham, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Wilmington, North Carolina, United States

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Minot, North Dakota, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Kettering, Ohio, United States

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Poland, Ohio, 44514, United States

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Steubenville, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bend, Oregon, United States

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Doylestown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenwood, South Carolina, United States

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Spartanburg, South Carolina, United States

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West Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Lynchburg, Virginia, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: OptiVol Care Pathway Clinical Team
• Organization: Medtronic Cardiac Rhythm Disease Management

medtronicCRMtrials@medtronic.com

1-800-328-2518

Study Officials

• Wilson Tang, MD

  Department of Cardiovascular Medicine, Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-04

Locations

US (108)