OptiVol® Care Pathway

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Medtronic

Status and phase

Completed
Phase 4

Conditions

Heart Failure

Treatments

Other: Quarterly Review Arm
Other: Monthly 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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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