ArrythmiaVALIOSANCT02401659
Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems
An observational study of Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in Spain.
Trial summary
Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia
- What is being tested?
- CareLinK
- Type of treatment
- Medical device
- How many people
- 187 participants
- Where
- 4 sitesSpain
- Study dates
- May 2014to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.
Who may be able to join
- Patients- naïve in CareLink®:
- First implant patients, who initiate in CareLink®
- Replacements patients who initiate in CareLink.
- Long term users in CareLink®: patients in CareLink for more than a year.
- Both male and female
- More than 18 years old.
- Be at the disposal of using CareLink monitoring system.
- Complete informed consent and accept the conditions of CareLink system.
Who cannot join
- Less than 18 years old
- Suffer from any menthal pathology who prevents the patient to collaborate in the study.
- Be unable to understand or answer questionnaires in Spanish.
- Deny to continue in the study.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Santa Creu i Sant Pau
Barcelona, Catalonia
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario de Araba
Vitoria-Gasteiz, Basque Country
About this study
Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.
- Conditions
- Arrythmia
- Being tested
- CareLinK
- Keywords
- remote monitoring, satisfaction, telemonitoring, quality of life
- Medical subject headings
- Arrhythmias, Cardiac, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareLinKDevice
| Study group | Role | What they receive |
|---|---|---|
| naïve with CareLink | patients with a first implant of an implanted cardiac device naïve in CareLink or patients with a refill who have not used CareLink until the implant Receives: Device: CareLinK | |
| users of CareLink | patients with an implanted cardiac device who have used CareLink for more than one year Receives: Device: CareLinK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with telemedicine measured by the questionnaire in evaluation
Measured: 12 months
Secondary outcomes (2)
Satisfaction with medical treatment measured by visual analog scale
Measured: 12 months
Quality of Life measured by SF-36
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401659
- Sponsor's protocol ID
- T431 v 2.0
- Acronym
- VALIOSA
- Status last verified
- Nov 2017
- First submitted
- 17 Mar 2015
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems
- ClinicalTrials.gov ID
- NCT02401659
- Acronym / sponsor ID
- VALIOSA / T431 v 2.0
- Conditions
- Arrythmia
- Keywords
- remote monitoring, satisfaction, telemonitoring, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Valiosa is a national, multicenter and prospective post market study. The objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naïve with CareLink | – | Device: CareLinKpatients with a first implant of an implanted cardiac device naïve in CareLink or patients with a refill who have not used CareLink until the implant |
| users of CareLink | – | Device: CareLinKpatients with an implanted cardiac device who have used CareLink for more than one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.
Key inclusion criteria (8 listed)
- Patients- naïve in CareLink®:
- Long term users in CareLink®: patients in CareLink for more than a year.
- Both male and female
- More than 18 years old.
- Be at the disposal of using CareLink monitoring system.
Key exclusion criteria (4 listed)
- Less than 18 years old
- Suffer from any menthal pathology who prevents the patient to collaborate in the study.
- Be unable to understand or answer questionnaires in Spanish.
- Deny to continue in the study.
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 | Device | naïve with CareLink, users of CareLink |
Primary outcome
Satisfaction with telemedicine measured by the questionnaire in evaluation
Time frame: 12 months
2 secondary outcomes
Satisfaction with medical treatment measured by visual analog scale
Time frame: 12 months
Quality of Life measured by SF-36
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in Spain.
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 8 inclusion and 4 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 3 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 4 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction with telemedicine measured by the questionnaire in evaluation (time frame: 12 months). 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 3 Jul 2025.