N/A
Completed N=209
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
Complication of Cardiac Defibrillator
Source: ClinicalTrials.gov NCT01075516 ↗
Enrolled (actual)
209
Serious AEs
26.3%
Results posted
Mar 2021
Primary outcomePrimary: Economic Impact of Remote Monitoring on Hospitals and Patients — 1044.89; 482.87 Euro (€) — p=<0.0001
Summary
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Economic Impact of Remote Monitoring on Hospitals and Patients |
1044.89; 482.87 | <0.0001 sig |
| SECONDARY Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) |
886.67; 432.34 | 0.003 sig |
| SECONDARY Impact of Remote Monitoring on Patients' Quality of Life |
0.8621; 0.8686; 0.8463; 0.8703; 0.8542; 0.8694 | 0.80 |
Eligibility Criteria
Inclusion Criteria
- Patients already implanted with ICD
- Patients able to be followed in the same centre during all the study
- Patients with age > 18
- Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire
Exclusion Criteria
- Patients pregnant
- Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)
Data sourced from ClinicalTrials.gov (NCT01075516). 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.