Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Heart Failure Ventricular Tachycardia Cardiac Desynchronization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON

Group Type EXPERIMENTAL

Device triggered remote telephone contact because of Care Alert

Intervention Type BEHAVIORAL

Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed

2

No Care Alerts available, standard treatment of the patient

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Device triggered remote telephone contact because of Care Alert

Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed

Intervention Type BEHAVIORAL

Other Intervention Names

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OptiVol CareLink Medtronic Concerto Medtronic Consulta Medtronic Secura Medtronic Virtuoso

Eligibility Criteria

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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