Clinical trial NCT00847288: OptiVol® Care Pathway
Official title: OptiVol® Care Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy with Defibrillator (CRT D)
OptiVol®
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 1682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 1 year
Secondary outcomes:
measure: Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
timeFrame: 1 year
measure: Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Mesa
country: United States
state: Arizona
city: Ft. Smith
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Alhambra
country: United States
state: California
city: Berkeley
country: United States
state: California
city: Burbank
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Larkspur
country: United States
state: California
city: Pomona
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Torrance
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Brandenton
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Trinity
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state: Florida
city: Augusta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Kankakee
country: United States
state: Illinois
city: Oak Lawn
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Bloomington
country: United States
state: Indiana
city: Muncie
country: United States
state: Indiana
city: Munster
country: United States
state: Indiana
city: Terre Haute
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state: Indiana
city: Davenport
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Ashland
country: United States
state: Kentucky
city: Lexington
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state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Bangor
country: United States
state: Maine
city: Glen Burnie
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Grand Blanc
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Petosky
country: United States
state: Michigan
city: Sterling Heights
country: United States
state: Michigan
city: Coon Rapids
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: St. Cloud
country: United States
state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Bridgewater
country: United States
state: New Jersey
city: Galloway
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Ocean
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Fayetteville
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Gastonia
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Minot
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Poland
country: United States
state: Ohio
city: Steubenville
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Greenwood
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: West Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Lynchburg
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Department of Cardiovascular Medicine, Cleveland Clinic
name: Wilson Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: