Status:
COMPLETED
OptiVol® Care Pathway
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1682 Patients enrolled
Trial Details
Trial ID
NCT00847288
Start Date
March 1 2009
End Date
May 1 2011
Last Update
May 3 2013
Active Locations (108)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Anchorage, Alaska, United States
4
Mesa, Arizona, United States