OptiVol® Care Pathway - Full Text View

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Other: Monthly Review Arm Other: Quarterly Review Arm	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	OptiVol® Care Pathway

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score.

Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score.
Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.
Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	1682
Study Start Date:	March 2009
Study Completion Date:	May 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Monthly Review Arm Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly	Other: Monthly Review Arm Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Active Comparator: Quarterly Review Arm Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months	Other: Quarterly Review Arm Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847288

Show 108 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Principal Investigator:

Wilson Tang, MD

Department of Cardiovascular Medicine, Cleveland Clinic

More Information

No publications provided

Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00847288 History of Changes
Other Study ID Numbers:	OptiVol® Care Pathway
Study First Received:	February 13, 2009
Results First Received:	June 5, 2012
Last Updated:	April 30, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Heart Failure
Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy with Defibrillator (CRT D)
OptiVol®

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013