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Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

NCT00787683 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2012-06-26

No results posted yet for this study

Summary

The purpose of this study is to investigate the cost-effectiveness and effectiveness of remote-monitoring compared to standard care in patients with implantable cardioverter defibrillator.

Conditions

  • Ventricular Arrythmias

Interventions

DEVICE

Home-monitoring provided by LUMAX ICD device and CardioMessenger II

All study participants receive an ICD of the Biotronik lumax family. Only participants of the intervention group receive the CardioMessengerII to allow for transmission of regular home monitoring messages. All study participants will be followed for 12 to 24 months (depending on the time of recruitment). The intervention and comparison to be investigated is home-monitoring vs. no home-monitoring. The intervention involves a combination of in-clinic consultations and regular use of home-monitoring services. As part of the modified follow-up schedule of intervention patients compared to standard care, follow-up in-clinic consultations 3, 6, and 18 months after ICD implantation will be replaced by home-monitoring follow-up.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • F. Mueller-Riemenschneider

    lead OTHER

Principal Investigators

  • Markus Zabel, Prof., MD · Medical Faculty, University of Göttingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787683 on ClinicalTrials.gov