OptiVol® Care Pathway

Medtronic

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Other: Monthly Review Arm; Other: Quarterly Review Arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847288

OptiVol® Care Pathway

Details and patient eligibility

About

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.

Enrollment: 1,682 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,682 participants in 2 patient groups

Monthly Review Arm

Experimental group

Description:

Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly

Treatment:

Other: Monthly Review Arm

Quarterly Review Arm

Active Comparator group

Description:

Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months

Treatment:

Other: Quarterly Review Arm