Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Time to first hospitalization due to worsened heart failure
Study Overview
Brief Summary
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device
- •Patient consents to study
- •Ability to replace follow-ups with CareLink follow-ups
- •Ability to attend all follow-ups at study center
Exclusion Criteria
- •Permanent AF
- •Less than 18 years of age
- •Life expectancy less than 15 months
- •Participation in another clinical study
- •Pregnancy
Arms & Interventions
2
No Care Alerts available, standard treatment of the patient
1
Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON
Intervention: Device triggered remote telephone contact because of Care Alert (Behavioral)
Outcomes
Primary Outcomes
Time to first hospitalization due to worsened heart failure
Time Frame: 15 months
Secondary Outcomes
- Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making(15 months)