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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD traditional follow-up | Active Comparator | ICD with traditional follow-up in the outpatient clinic |
|
| Home-Monitoring | Active Comparator | Home-Monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Monitoring | Device | Home-Monitoring |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction with ICD therapy and follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of healthcare consultations | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kolb Christof | Deutsches Herzzentrum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Hezzentrum | München | Bavaria | 80636 | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2023 | |
| Reset | Jan 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2023 | Jan 3, 2024 |
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| Follow-up by Home-Monitoring |
| Device |
Follow-up by Home-Monitoring |
|