Clinical Trials Directory

Trials / Completed

CompletedNCT03125382

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
141 (actual)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

Detailed description

The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.

Conditions

Interventions

TypeNameDescription
DEVICECarelink SystemPatients start to perform device data transmission through Carelink system
DEVICEIn office standard visitPatients start or maintain in office standard visits

Timeline

Start date
2012-04-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2017-04-24
Last updated
2025-07-02
Results posted
2024-02-05

Locations

6 sites across 1 country: Portugal

Source: ClinicalTrials.gov record NCT03125382. Inclusion in this directory is not an endorsement.