OptiVol® Care Pathway

Completed · Phase 4

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00847288

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

1682

Starts

2009-03-01

Expected to finish

2011-05-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Mesa, Arizona, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Alhambra, California, United States
• Study site — Berkeley, California, United States
• Study site — Burbank, California, United States
• Study site — Chula Vista, California, United States
• Study site — La Jolla, California, United States
• Study site — Larkspur, California, United States
• Study site — Pomona, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Riverside, California, United States
• Study site — San Francisco, California, United States
• Study site — Torrance, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Brandenton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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