Overview

This trial is active, not recruiting.

Condition improvement of treatment satisfaction
Treatments home-monitoring, follow-up by home-monitoring
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Start date February 2011
End date July 2014
Trial size 120 participants
Trial identifier NCT01230073, GER-EP-004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
ICD with traditional follow-up in the outpatient clinic
home-monitoring
Home-Monitoring
follow-up by home-monitoring
Follow-up by Home-Monitoring
(Active Comparator)
Home-Monitoring
home-monitoring
Home-Monitoring
follow-up by home-monitoring
Follow-up by Home-Monitoring

Primary Outcomes

Measure
Treatment satisfaction with ICD therapy and follow-up
time frame: 12 months

Secondary Outcomes

Measure
Number of healthcare consultations
time frame: 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
Principal investigator Kolb Christof
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.