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Completed

NCT Number: NCT03125382

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)

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Hospitalar do Algarve, Faro, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carelink System

Device

Patients start to perform device data transmission through Carelink system

In office standard visit

Device

Patients start or maintain in office standard visits

Primary outcomes

  1. Number of Patient Satisfied or Very Satisfied With Carelink

    Time frame: 12 months visit

    through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied

Secondary outcomes

  1. Number of Device Related Adverse Events

    Time frame: 12 months visit

    compare number of Device-related Adverse Events

  2. Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings

    Time frame: 12 months visit

    Through the semi-quantitative evaluation of physician satisfaction with CareLink System.

    Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied"

  3. Health Care Consumed Resources Between Groups Relative to Unscheduled Visits

    Time frame: 12 months visit

    Number of in office unscheduled visits will be calculated per arm and compared with each other

  4. Compare Patient Consumed Resources Between Groups

    Time frame: Baseline

    Attribute patient travel costs to low, middle and high costs and then compare patient travel costs between the group with in office visits versus Carelink, measured at baseline

  5. Compare Patient Consumed Resources Between Groups

    Time frame: Baseline

    Patient time consumption in visits between the groups at baseline visit

    Arms were combine:

    • In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous
    • Carelink combine: Carelink - New Implants & Carelink - Previous

  6. Improvement in Quality of Life

    Time frame: 12 months visit

    Health-related quality of life was measured with an adapted version of the SF-12 questionnaire, a 12-item generic measure derived from the Short-Form 36. It evaluates physical functioning, limitations due to physical health problems, bodily pain, energy/fatigue, social functioning, limitations due to emotional problems, and psychological distress and well-being. Physica lcomponent summary and mental component summary measures were estimated, with higher scores indicating better health status (range from 0 to 100).

    Mental health wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS), which consists of a series of 14 questions, seven related to anxiety (HAD-A) plus other seven questions related to depression (HAD-D). Scores of 0-7 for the two subscales are regarded as normal, scores of 8-10 suggest the presence of a mood disorder and scores ≥11 suggest a probable mood disorder.

  7. Number of Unanticipated Serious Adverse Device Effects (USADE) Rate

    Time frame: 12 months visit

    compare number of Unanticipated Serious Adverse Device Effects (USADE)

    Arms were combine:

    • In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous
    • Carelink combine: Carelink - New Implants & Carelink - Previous

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: PORTLink

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2017
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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