NCT02401659

Brief 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 makers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 3, 2025

Status Verified

November 1, 2017

Enrollment Period

3.4 years

First QC Date

March 17, 2015

Last Update Submit

June 30, 2025

Conditions

Keywords

remote monitoringsatisfactiontelemonitoringquality of life

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with telemedicine measured by the questionnaire in evaluation

    12 months

Secondary Outcomes (2)

  • Satisfaction with medical treatment measured by visual analog scale

    12 months

  • Quality of Life measured by SF-36

    12 months

Study Arms (2)

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

Device: CareLinK

users of CareLink

patients with an implanted cardiac device who have used CareLink for more than one year

Device: CareLinK

Interventions

CareLinKDEVICE
naïve with CareLinkusers of CareLink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an implantable cardiac device and using CareLink® program for the remote monitoring of the device.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Universitario de Araba

Vitoria-Gasteiz, Basque Country, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

MeSH Terms

Conditions

Arrhythmias, CardiacPersonal Satisfaction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 30, 2015

Study Start

May 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 3, 2025

Record last verified: 2017-11

Locations