Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients (SAN REMO 2)

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Improvement of Treatment Satisfaction

Treatments: Device: Follow-up by Home-Monitoring; Device: Home-Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01230073

GER-EP-004

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

ICD traditional follow-up

Active Comparator group

Description:

ICD with traditional follow-up in the outpatient clinic

Treatment:

Device: Home-Monitoring

Device: Follow-up by Home-Monitoring

Home-Monitoring

Active Comparator group

Description:

Home-Monitoring

Treatment:

Device: Home-Monitoring

Device: Follow-up by Home-Monitoring