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Clinical Trials/NCT01230073
NCT01230073
Completed
Phase 4

Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients

Deutsches Herzzentrum Muenchen1 site in 1 country120 target enrollmentFebruary 2011

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum Muenchen
Responsible Party
Sponsor

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)

Study Sites (1)

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