Clinical trial NCT03125382: PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Official title: PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patient Satisfied or Very Satisfied With Carelink
timeFrame: 12 months visit
Secondary outcomes:
measure: Number of Device Related Adverse Events
timeFrame: 12 months visit
measure: Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings
timeFrame: 12 months visit
measure: Health Care Consumed Resources Between Groups Relative to Unscheduled Visits
timeFrame: 12 months visit
measure: Compare Patient Consumed Resources Between Groups
timeFrame: Baseline
measure: Compare Patient Consumed Resources Between Groups
timeFrame: Baseline
measure: Improvement in Quality of Life
timeFrame: 12 months visit
measure: Number of Unanticipated Serious Adverse Device Effects (USADE) Rate
timeFrame: 12 months visit
Other outcomes:
Locations:
city: Faro
country: Portugal
facility: Hospital Hospitalar do Algarve
city: Guimarães
country: Portugal
facility: Centro Hospitalar de Alto Ave - Unidade de Guimarães
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Central- Hospital de Santa Marta
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Setúbal
country: Portugal
facility: Centro Hospitalar de Setúbal
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
Study officials:
affiliation: Centro Hospitalar Lisboa Central
name: Mário Oliveira, Doctor
role: PRINCIPAL_INVESTIGATOR
References: