Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients

Phase 4

Completed

• Conditions: Improvement of Treatment Satisfaction
• Interventions: Device: Home-Monitoring; Device: Follow-up by Home-Monitoring

• Registration Number: NCT01230073
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Study Start: 2011-02
• Primary Completion: 2014-07
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICD traditional follow-up	Follow-up by Home-Monitoring	ICD with traditional follow-up in the outpatient clinic
Home-Monitoring	Home-Monitoring	Home-Monitoring
ICD traditional follow-up	Home-Monitoring	ICD with traditional follow-up in the outpatient clinic
Home-Monitoring	Follow-up by Home-Monitoring	Home-Monitoring

Primary Outcome Measures

Name	Time	Method
Treatment satisfaction with ICD therapy and follow-up	12 months

Secondary Outcome Measures

Name	Time	Method
Number of healthcare consultations	12 months

Trial Locations

Locations (1)

Deutsches Hezzentrum; 🇩🇪 München, Bavaria, Germany