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

Medtronic

Status: Completed

Conditions: Arrythmia

Treatments: Device: CareLinK

Study type: Observational

Funder types: Industry

Identifiers

NCT02401659

T431 v 2.0

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

187 participants in 2 patient groups

naïve with CareLink

Description:

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

Treatment:

Device: CareLinK

users of CareLink

Description:

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

Treatment:

Device: CareLinK