ICD or CRT-D carriers ICD or CRT-D patients
Conditions
Interventions
Participants use a mobile application for registering their symptoms. In the background, these symptoms will be linked to ICD data, the standard care will not be adjusted.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Implanted with a Gallant* ICD or CRT-D device - Participation in the remote monitoring program at AUMC - Patients >=18 years old
Exclusion criteria
Exclusion criteria: - Not able to provide written informed consent - Not able to use the Castor Connect application - A life expectancy of less than one year - Insufficient understanding of the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the actionability of the follow-up action corresponding to each remote device and symptom transmission. Second endpoint is the usability, assessed by evaluating the ease of use through a standardized questionnaire (UMUX) and semi-structured interviews (n=5). Moreover, the data collected during this study will be used to develop an automated triage algorithm for remote transmissions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional secondary endpoints will contain the results of the EQ-5D, KCCQ-12, and HADS questionnaires and primary outcome measures for a subsequent randomized controlled trial (e.g. non-actionable in-person evaluations, safety endpoint (MACE/SAE), appropriate and inappropriate ICD-therapy, quality of life, anxiety scores, and time to diagnosis of a clinical event). | — |
Countries
Netherlands
Contacts
Public ContactF.D. Raijmakers
Amsterdam UMC
Outcome results
None listed