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

NCT ID: NCT02401659

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arrythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

CareLinK

Intervention Type DEVICE

users of CareLink

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

CareLinK

Intervention Type DEVICE

Interventions

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CareLinK

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients- naïve in CareLink®:

* First implant patients, who initiate in CareLink®
* Replacements patients who initiate in CareLink.
2. Long term users in CareLink®: patients in CareLink for more than a year.
3. Both male and female
4. More than 18 years old.
5. Be at the disposal of using CareLink monitoring system.
6. Complete informed consent and accept the conditions of CareLink system.

Exclusion Criteria

1. Less than 18 years old
2. Suffer from any menthal pathology who prevents the patient to collaborate in the study.
3. Be unable to understand or answer questionnaires in Spanish.
4. Deny to continue in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario de Araba

Vitoria-Gasteiz, Basque Country, Spain

Site Status

Hospital Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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T431 v 2.0

Identifier Type: -

Identifier Source: org_study_id

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