PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

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

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.

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