N/A
Completed N=141
PORTuguese Research on Telemonitoring With CareLink® (PORTLink)
Source: ClinicalTrials.gov NCT03125382 ↗Enrolled (actual)
141
Serious AEs
4.5%
Results posted
Feb 2024
Primary outcomePrimary: Number of Patient Satisfied or Very Satisfied With Carelink — 34; 34 Participants
Summary
Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patient Satisfied or Very Satisfied With Carelink |
34; 34 | — |
| SECONDARY Number of Device Related Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings |
98; 80; 25; 47; 0; 0 | — |
| SECONDARY Health Care Consumed Resources Between Groups Relative to Unscheduled Visits |
1.1; 0.4 | — |
| SECONDARY Compare Patient Consumed Resources Between Groups |
30; 30; 80; 95 | — |
| SECONDARY Compare Patient Consumed Resources Between Groups |
30; 30; 80; 95 | — |
| SECONDARY Improvement in Quality of Life |
0; 0; 0; 0; -1.1; 0.0 | — |
| SECONDARY Number of Unanticipated Serious Adverse Device Effects (USADE) Rate |
6; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has implanted Medtronic Implantable Cardioverter Defibrillator: CRT-D (Cardiac Resynchronization Therapy - Defibrillator), ICD
- Subject or the subject's caregiver is willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant to perform those studies
- Subject has signed a Patient Informed Consent Form from this study
Exclusion Criteria
- Subject has medical condition(s) that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available)
- Subject is less than 18 years of age
- Subject is enrolled or intends to participate in another clinical trial
Data sourced from ClinicalTrials.gov (NCT03125382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.