PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Study Overview
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Brief Summary
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Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac desfibrilator (ICD)

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 CID 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.

Official Title
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PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Conditions
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Arrhythmia

Intervention / Treatment
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* Device: Carelink System
* Device: In office standard visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In office standard visit-New<br>Patients with new implants who do not perform device data transmission through Carelink system | Device: In office standard visit<br>* Patients start or mantain in office standard visits<br>|
| Active Comparator: In office standard visit-Previous<br>Patients with previous implants who do not perform device data transmission through Carelink system | Device: In office standard visit<br>* Patients start or mantain in office standard visits<br>|
| Experimental: Carelink - New Implants<br>Patients with new implants who perform device data transmission through Carelink system | Device: Carelink System<br>* Patients start to perform device data transmission through Carelink system<br>|
| Experimental: Carelink - Previous Implants<br>Patients with previous implants who perform device data transmission through Carelink system | Device: Carelink System<br>* Patients start to perform device data transmission through Carelink system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with carelink | through the semi-quantitative evaluation of patient satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up | 12 months after the end of recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of device-related adverse events and unanticipated serious adverse device effects (USADE) rate |  | 12 months after the end of recruitment | 
| Physician satisfaction with carelink | Through the semi-quantitative evaluation of physician satisfaction with CareLink System and their preference when compared to traditional in-clinic follow-up | 12 months after the end of recruitment | 
| Comparation of health care consumed resources between groups | Number of unscheduled visits and visit duration | 12 months after the end of recruitment | 
| Comparation of patient consumed resources between groups | Patient costs and time consuption | 12 months after the end of recruitment | 
| Quality of life | Through SF-12 and HADS | 12 months after the end of recruitment |