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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly Review Arm | Experimental | Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly Review Arm | Other | Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management. |
|
| Measure | Description | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilson Tang, MD | Department of Cardiovascular Medicine, Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
There were 1682 enrollments from 106 study centers. 1668 of those enrollments met the inclusion criteria for the study and thus were randomized. Fourteen did not meet the inclusion criteria and were excluded before randomization.
The recruitment period of OptiVol Care Pathway Study was from April 2, 2009 to March 7, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monthly Review Arm | Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly |
| FG001 | Quarterly Review Arm | Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Quarterly Review Arm | Other | Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management. |
|
| 1 year |
| 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. | 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 |
| Mobile |
| Alabama |
| United States |
| Anchorage | Alaska | United States |
| Mesa | Arizona | United States |
| Fort Smith | Arkansas | United States |
| Little Rock | Arkansas | United States |
| 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 | 91767 | United States |
| Rancho Mirage | California | United States |
| Riverside | California | United States |
| San Francisco | California | 94115 | United States |
| Torrance | California | United States |
| Boulder | Colorado | United States |
| Colorado Springs | Colorado | United States |
| Brandenton | Florida | United States |
| Clearwater | Florida | United States |
| Daytona Beach | Florida | United States |
| Fort 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 |
| Augusta | Georgia | United States |
| Columbus | Georgia | United States |
| Chicago | Illinois | United States |
| Kankakee | Illinois | United States |
| Oak Lawn | Illinois | United States |
| Rockford | Illinois | United States |
| Bloomington | Indiana | United States |
| Muncie | Indiana | United States |
| Munster | Indiana | United States |
| Terre Haute | Indiana | United States |
| Davenport | Iowa | United States |
| Des Moines | Iowa | United States |
| Ashland | Kentucky | United States |
| Lexington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Shreveport | Louisiana | United States |
| Bangor | Maine | United States |
| Glen Burnie | Maryland | United States |
| Rockville | Maryland | United States |
| Salisbury | Maryland | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | 48236 | United States |
| Grand Blanc | Michigan | United States |
| Grand Rapids | Michigan | United States |
| Petosky | Michigan | United States |
| Sterling Heights | Michigan | United States |
| Coon Rapids | Minnesota | United States |
| Minneapolis | Minnesota | United States |
| Saint Cloud | Minnesota | United States |
| Columbia | Missouri | United States |
| Kansas City | Missouri | United States |
| Saint Joseph | Missouri | United States |
| Springfield | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Reno | Nevada | United States |
| Bridgewater | New Jersey | United States |
| Galloway | New Jersey | United States |
| Newark | New Jersey | 07105 | United States |
| Ocean City | New Jersey | 07712 | United States |
| Voorhees Township | New Jersey | United States |
| Buffalo | New York | United States |
| Fayetteville | New York | United States |
| Garden City | New York | 11530 | United States |
| Durham | North Carolina | United States |
| Gastonia | North Carolina | United States |
| Greensboro | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Minot | North Dakota | United States |
| Akron | Ohio | United States |
| Cleveland | Ohio | United States |
| Kettering | Ohio | United States |
| Poland | Ohio | 44514 | United States |
| Steubenville | Ohio | United States |
| Toledo | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Bend | Oregon | United States |
| Doylestown | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Wynnewood | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Greenwood | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| West Columbia | South Carolina | United States |
| Germantown | Tennessee | United States |
| Johnson City | Tennessee | United States |
| Memphis | Tennessee | 38120 | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Corpus Christi | Texas | United States |
| McAllen | Texas | United States |
| San Antonio | Texas | United States |
| Tyler | Texas | United States |
| Lynchburg | Virginia | United States |
| Spokane | Washington | United States |
| Madison | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monthly Review Arm | Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly |
| BG001 | Quarterly Review Arm | Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | inches |
| |||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
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| Systolic blood pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis. | Posted | Median | 95% Confidence Interval | months | 1 year |
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| Secondary | 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. | For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following: Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo. | Posted | Mean | Standard Deviation | units on a scale | 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage of visits with action | 1 year | visits | Participants |
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| Secondary | 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 | Posted | Median | 95% Confidence Interval | months | 1 year |
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Adverse Events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monthly Review Arm | Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly | 0 | 0 | 0 | 0 | ||
| EG001 | Quarterly Review Arm | Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| OptiVol Care Pathway Clinical Team | Medtronic Cardiac Rhythm Disease Management | 1-800-328-2518 | medtronicCRMtrials@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Black |
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| American Indian |
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| Asian |
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| Hawaiian |
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| Hispanic |
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| Multiple |
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| Other |
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| Not Available |
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| No |
| Superiority or Other |
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months |
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| Participants |
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| visits |
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