PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

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

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-10-31

Brief Summary

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Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

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Detailed Description

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The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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In office standard visit-New

Patients with new implants who do not perform device data transmission through Carelink system

Group Type ACTIVE_COMPARATOR

In office standard visit

Intervention Type DEVICE

Patients start or maintain in office standard visits

In office standard visit-Previous

Patients with previous implants who do not perform device data transmission through Carelink system

Group Type ACTIVE_COMPARATOR

In office standard visit

Intervention Type DEVICE

Patients start or maintain in office standard visits

Carelink - New Implants

Patients with new implants who perform device data transmission through Carelink system

Group Type EXPERIMENTAL

Carelink System

Intervention Type DEVICE

Patients start to perform device data transmission through Carelink system

Carelink - Previous Implants

Patients with previous implants who perform device data transmission through Carelink system

Group Type EXPERIMENTAL

Carelink System

Intervention Type DEVICE

Patients start to perform device data transmission through Carelink system

Interventions

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Carelink System

Patients start to perform device data transmission through Carelink system

Intervention Type DEVICE

In office standard visit

Patients start or maintain in office standard visits

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
* Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
* Subject has signed a Patient Informed Consent Form from this study

Exclusion Criteria

* Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
* Subject is less than 18 years of age
* Subject is enrolled or intends to participate in another clinical trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No