Importance of Patient´s Satisfaction With Telemedicine Ba... | NCT02401659

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

NCT02401659

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

187Actual

Phase

Not provided

Conditions

Arrythmia

Interventions

CareLinK

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Mar 17, 2015

First Submission Date that Met QC Criteria

Mar 24, 2015

First Posted Date

Mar 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CareLinK	Device		naïve with CareLink users of CareLink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction with telemedicine measured by the questionnaire in evaluation		12 months

Secondary Outcomes

Measure	Description	Time Frame
Satisfaction with medical treatment measured by visual analog scale		12 months
Quality of Life measured by SF-36		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario de Araba		Vitoria-Gasteiz	Basque Country		Spain
Hospital Santa Creu i Sant Pau

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided