Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Improvement of Treatment Satisfaction
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Treatment satisfaction with ICD therapy and follow-up
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ICD indication according to current national or international guidelines
- •Patient available for follow-up during study period
Exclusion Criteria
- •Clinically unstable medical conditions that require regular outpatient clinic follow-up
Outcomes
Primary Outcomes
Treatment satisfaction with ICD therapy and follow-up
Time Frame: 12 months
Secondary Outcomes
- Number of healthcare consultations(12 months)