OptiVol Care Pathway
Eligibility
Persons may be eligible to participate in this trial if they meet the following criteria.
- Written consent from subject
- at least 18 years of age
- Compliance with Clinical Investigative Plan
- Willing and able to transmit data appropriately
- Medtronic implanted cardioverter device
Persons may be excluded from this trial if they meet the following criteria.
- Subject enrolled in a concurrent study, except as approved
- Life expectancy of less than 1 year
Complete Title
OptiVol Care Pathway
Purpose
To compare monthly versus quarterly review of CardiacCompass Trends with OptiVol for initiation of clinical action.
Summary
The OptiVol Clinical Pathway Study is a prospective, randomized, mulit-cetner, post-market clinical trial in the United States. The data collection study compares quarterly versus monthly review of Cardiac Compass Trends for shortened time to clinical action. Subjects must be implanted with a Medtronic ICD and be willing to transmit data using Medtronic CareLink.
Sponsor(s)
- Medtronic Cardiac Rhythm Disease Management