CareLink® Network Evaluation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.

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Detailed Description

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Evaluation's objectives:

Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Medtronic CareLink® Network

Patients with implanted Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.

The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.

Medtronic CareLink® Network

Intervention Type OTHER

The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website

Interventions

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Medtronic CareLink® Network

The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have an implanted Medtronic ICD, CRT-D device that is supported by the Medtronic CareLink® Network
* Patients have to sign the Medtronic CareLink® "Statement of Privacy Principles" and the "Evaluation Data Protection Statement" documents