Heart Failure
Conditions
Keywords
Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy with Defibrillator (CRT D), OptiVol®
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.
Interventions
OTHERMonthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
OTHERQuarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | 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. |
| Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews | 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. |
| 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 | — |
Countries
United States
Participant flow
Recruitment details
The recruitment period of OptiVol Care Pathway Study was from April 2, 2009 to March 7, 2011.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Monthly Review Arm Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly | 841 |
| Quarterly Review Arm Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months | 827 |
| Total | 1,668 |
Baseline characteristics
| Characteristic | Monthly Review Arm | Total | Quarterly Review Arm |
|---|---|---|---|
| Age Continuous | 68.3 years STANDARD_DEVIATION 11.8 | 68.0 years STANDARD_DEVIATION 11.7 | 67.6 years STANDARD_DEVIATION 11.6 |
| Diastolic blood pressure | 69.2 mmHg STANDARD_DEVIATION 10.1 | 70.8 mmHg STANDARD_DEVIATION 10.5 | 72.4 mmHg STANDARD_DEVIATION 10.7 |
| Height | 68.2 inches STANDARD_DEVIATION 4 | 68.1 inches STANDARD_DEVIATION 4.1 | 68.1 inches STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized American Indian | 5 participants | 7 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 12 participants | 8 participants |
| Race/Ethnicity, Customized Black | 53 participants | 151 participants | 98 participants |
| Race/Ethnicity, Customized Hawaiian | 2 participants | 4 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 20 participants | 89 participants | 69 participants |
| Race/Ethnicity, Customized Multiple | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Not Available | 5 participants | 25 participants | 20 participants |
| Race/Ethnicity, Customized Other | 3 participants | 7 participants | 4 participants |
| Race/Ethnicity, Customized White | 749 participants | 1370 participants | 621 participants |
| Sex: Female, Male Female | 238 Participants | 462 Participants | 224 Participants |
| Sex: Female, Male Male | 603 Participants | 1206 Participants | 603 Participants |
| Systolic blood pressure | 118.6 mmHg STANDARD_DEVIATION 17 | 120.6 mmHg STANDARD_DEVIATION 17.2 | 122.7 mmHg STANDARD_DEVIATION 17.1 |
| Weight | 196.5 lbs STANDARD_DEVIATION 45.9 | 196.3 lbs STANDARD_DEVIATION 47.4 | 196.1 lbs STANDARD_DEVIATION 48.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Monthly Review Arm | 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 | 8.9 months |
| Quarterly Review Arm | 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 | 12.4 months |
Comparison: Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio.p-value: 0.004395% CI: [1.1, 2]Regression, Cox
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Management (12 mo) | -2.32 units on a scale | Standard Deviation 24.96 |
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Confidence (12 mo) | 0.32 units on a scale | Standard Deviation 21.64 |
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Maintenance (6 mo) | 1.94 units on a scale | Standard Deviation 13.31 |
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Management (6 mo) | -1.72 units on a scale | Standard Deviation 24.33 |
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Confidence (6 mo) | -1.19 units on a scale | Standard Deviation 20.71 |
| Monthly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Maintenance (12 mo) | 1.1 units on a scale | Standard Deviation 13.16 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Confidence (6 mo) | -2.46 units on a scale | Standard Deviation 20.96 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Management (12 mo) | -4.17 units on a scale | Standard Deviation 25.27 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Management (6 mo) | -1.05 units on a scale | Standard Deviation 22.99 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Confidence (12 mo) | -1.74 units on a scale | Standard Deviation 22.65 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Maintenance (12 mo) | -1.42 units on a scale | Standard Deviation 14.73 |
| Quarterly Review Arm | Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm | Maintenance (6 mo) | -0.77 units on a scale | Standard Deviation 13.65 |
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
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Monthly Review Arm | 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 | 9.0 months |
| Quarterly Review Arm | 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 | 13.2 months |
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Monthly Review Arm | Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews | 0.26 percentage of visits with action |
| Quarterly Review Arm | Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews | 0.19 percentage of visits with action |
Comparison: The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.p-value: 0.000195% CI: [1.2, 1.74]logistic GEE for repeated observations