CareLink® Network Evaluation

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Other: Medtronic CareLink® Network

Study type: Observational

Funder types: Industry

Identifiers

NCT01023022

MDT-CareLinkEval

Details and patient eligibility

About

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

Full description

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.)

Enrollment: 176 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Patients with exclusion criteria required by local law
• Patient is anticipated to demonstrate poor compliance (for example, mental disturbances)

Trial design

176 participants in 1 patient group

Medtronic CareLink® Network

Description:

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.

Treatment:

Other: Medtronic CareLink® Network