Phase 4
Completed N=1,668
OptiVol® Care Pathway
Source: ClinicalTrials.gov NCT00847288 ↗Enrolled (actual)
1,668
Serious AEs
—
Results posted
May 2013
Primary outcomePrimary: 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; 12.4 months — p=0.0043
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
8.9; 12.4 | 0.0043 sig |
| SECONDARY Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm |
1.94; -0.77; -1.72; -1.05; -1.19; -2.46 | — |
| SECONDARY Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews |
0.26; 0.19 | 0.0001 sig |
| 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 |
9.0; 13.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00847288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.