CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,682 enrolled
Drug / intervention
Monthly Review Arm +1 moreother
Likely dose
Monthly vs. quarterly remote monitoring review of OptiVol Fluid Status Trends via Medtronic CareLink NetworkAI-extracted
Key inclusion· 4
  • ✓Age at least 18 years old
  • ✓Willing and able to comply with the Clinical Investigation Plan
  • ✓Able to transmit data via Medtronic CareLink Network
  • ✓Has implanted compatible Medtronic ICD or CRT-D generator with OptiVol and wireless telemetry support
Key exclusion· 2
  • ✕Enrolled in a concurrent study (unless approved by Medtronic Clinical Trial Leader)
  • ✕Life expectancy less than 1 year

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00847288
NCT00847288Phase 4Completed
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OptiVol® Care Pathway

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Feb 19, 2009·Updated May 3, 2013

In Brief

A Phase 4 clinical trial evaluating Monthly Review Arm and Quarterly Review Arm for Heart Failure. Completed, enrolled 1,682 participants across 108 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.4 years ago

Interventions

Monthly Review Armother

Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

Quarterly Review Armother

Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.