PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Medtronic

Status: Completed

Conditions: Arrhythmia

Treatments: Device: Carelink System; Device: In office standard visit

Study type: Interventional

Funder types: Industry

Identifiers

NCT03125382

PORTLink

Details and patient eligibility

About

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

Full description

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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 4 patient groups

In office standard visit-New

Active Comparator group

Description:

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

Treatment:

Device: In office standard visit

In office standard visit-Previous

Active Comparator group

Description:

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

Treatment:

Device: In office standard visit

Carelink - New Implants

Experimental group

Description:

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

Treatment:

Device: Carelink System

Carelink - Previous Implants

Experimental group

Description:

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

Treatment:

Device: Carelink System