ArrhythmiaPORTLinkNCT03125382
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
A study testing Carelink System and In office standard visit in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Portugal.
Trial summary
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Carelink System and In office standard visit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 6 sitesPortugal
- Study dates
- Apr 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Portugal6 sites
Hospital Hospitalar do Algarve
Faro, 8000-386
Centro Hospitalar de Alto Ave - Unidade de Guimarães
Guimarães, 4835-044
Centro Hospitalar Lisboa Central- Hospital de Santa Marta
Lisbon, 1169-1024
Centro Hospitalar do Porto
Porto, 4099-001
Centro Hospitalar de Setúbal
Setúbal, 2910 - 446
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4434-502
About this study
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- Carelink System, In office standard visit
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carelink SystemDevice
Patients start to perform device data transmission through Carelink system
In office standard visitDevice
Patients start or maintain in office standard visits
| Study group | Role | What they receive |
|---|---|---|
| In office standard visit-New | Active comparator | Patients with new implants who do not perform device data transmission through Carelink system Receives: Device: In office standard visit |
| In office standard visit-Previous | Active comparator | Patients with previous implants who do not perform device data transmission through Carelink system Receives: Device: In office standard visit |
| Carelink - New Implants | Experimental | Patients with new implants who perform device data transmission through Carelink system Receives: Device: Carelink System |
| Carelink - Previous Implants | Experimental | Patients with previous implants who perform device data transmission through Carelink system Receives: Device: Carelink System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patient Satisfied or Very Satisfied With Carelink
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
Measured: 12 months visit
Secondary outcomes (7)
Number of Device Related Adverse Events
compare number of Device-related Adverse Events
Measured: 12 months visit
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings
Through the semi-quantitative evaluation of physician satisfaction with CareLink System.
Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied"
Measured: 12 months visit
Health Care Consumed Resources Between Groups Relative to Unscheduled Visits
Number of in office unscheduled visits will be calculated per arm and compared with each other
Measured: 12 months visit
Compare Patient Consumed Resources Between Groups
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
Measured: Baseline
Compare Patient Consumed Resources Between Groups
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
Measured: Baseline
Improvement in Quality of Life
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.
Measured: 12 months visit
Number of Unanticipated Serious Adverse Device Effects (USADE) Rate
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
Measured: 12 months visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startApr 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mário Oliveira, Doctor, Principal investigator, Centro Hospitalar de Lisboa Central
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125382
- Sponsor's protocol ID
- PORTLink
- Acronym
- PORTLink
- Status last verified
- May 2023
- First submitted
- 25 May 2016
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
- ClinicalTrials.gov ID
- NCT03125382
- Acronym / sponsor ID
- PORTLink / PORTLink
- Conditions
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| In office standard visit-New | Active comparator | Device: In office standard visitPatients with new implants who do not perform device data transmission through Carelink system |
| In office standard visit-Previous | Active comparator | Device: In office standard visitPatients with previous implants who do not perform device data transmission through Carelink system |
| Carelink - New Implants | Experimental | Device: Carelink SystemPatients with new implants who perform device data transmission through Carelink system |
| Carelink - Previous Implants | Experimental | Device: Carelink SystemPatients with previous implants who perform device data transmission through Carelink system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carelink SystemPatients start to perform device data transmission through Carelink system | Device | Carelink - New Implants, Carelink - Previous Implants |
| In office standard visitPatients start or maintain in office standard visits | Device | In office standard visit-New, In office standard visit-Previous |
Primary outcome
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
7 secondary outcomes
Number of Device Related Adverse Events
Time frame: 12 months visit
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings
Time frame: 12 months visit
Health Care Consumed Resources Between Groups Relative to Unscheduled Visits
Time frame: 12 months visit
Compare Patient Consumed Resources Between Groups
Time frame: Baseline
Compare Patient Consumed Resources Between Groups
Time frame: Baseline
Improvement in Quality of Life
Time frame: 12 months visit
Number of Unanticipated Serious Adverse Device Effects (USADE) Rate
Time frame: 12 months visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mário Oliveira, Doctor principal investigator
Centro Hospitalar de Lisboa Central
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carelink System and In office standard visit in people with Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patient Satisfied or Very Satisfied With Carelink (time frame: 12 months visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.