Back to resultsOptiVol® Care Pathway
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Monthly Review Arm
Quarterly Review Arm
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy with Defibrillator (CRT D), OptiVol®
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monthly Review Arm
Quarterly Review Arm
Arm Description
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT00847288
First Posted
February 13, 2009
Last Updated
April 30, 2013
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT00847288
Brief Title
OptiVol® Care Pathway
Official Title
OptiVol® Care Pathway
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy with Defibrillator (CRT D), OptiVol®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1682 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monthly Review Arm
Arm Type
Experimental
Arm Description
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Arm Title
Quarterly Review Arm
Arm Type
Active Comparator
Arm Description
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Intervention Type
Other
Intervention Name(s)
Monthly Review Arm
Intervention Description
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Intervention Type
Other
Intervention Name(s)
Quarterly Review Arm
Intervention Description
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Description
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.
Time Frame
1 year
Title
Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews
Description
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.
Time Frame
1 year
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Tang, MD
Organizational Affiliation
Department of Cardiovascular Medicine, Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
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Alabama
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United States
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Mobile
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United States
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Anchorage
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Alaska
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Mesa
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Ft. Smith
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Little Rock
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Berkeley
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Chula Vista
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La Jolla
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Larkspur
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Pomona
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91767
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Rancho Mirage
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Riverside
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San Francisco
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94115
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Torrance
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Boulder
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Colorado Springs
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Kankakee
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Bloomington
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Petosky
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Galloway
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07105
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Ocean
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07712
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Voorhees
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Buffalo
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Fayetteville
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Garden City
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New York
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11530
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Durham
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Gastonia
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Minot
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Cleveland
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Kettering
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Poland
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44514
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United States
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Steubenville
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Toledo
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Oklahoma City
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Bend
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Doylestown
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Lancaster
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Wynnewood
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Columbia
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Greenwood
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Spartanburg
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West Columbia
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South Carolina
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Germantown
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Johnson City
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Memphis
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Tennessee
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38120
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United States
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Nashville
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United States
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Austin
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United States
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Corpus Christi
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McAllen
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San Antonio
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Tyler
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Spokane
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United States
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Madison
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Wisconsin
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United States
12. IPD Sharing Statement
Learn more about this trial
OptiVol® Care Pathway
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