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OpenTrials
Completed

NCT Number: NCT02401659

Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems

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.

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Araba, Vitoria-Gasteiz, Basque Country, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CareLinK

Device

Primary outcomes

  1. Satisfaction with telemedicine measured by the questionnaire in evaluation

    Time frame: 12 months

Secondary outcomes

  1. Satisfaction with medical treatment measured by visual analog scale

    Time frame: 12 months

  2. Quality of Life measured by SF-36

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: VALIOSA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2015
Registry last updated
Jul 3, 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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