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
| Type | Name | Description |
|---|---|---|
| DEVICE | Carelink System | Patients start to perform device data transmission through Carelink system |
| DEVICE | In office standard visit | Patients 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.