NCT00787683

Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

Home-Monitoring in ICD Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: F. Mueller-Riemenschneider · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Implantable cardioverter defibrillator (ICD) are an important and effective treatment in patients at risk of sudden cardiac death. In order to allow for a more continuous follow-up and reduced complication rates of patients with ICD, new devices including remote-monitoring (home-monitoring) features of patients with ICD have been developed. BIOTRONIK Home Monitoring service enables the doctors to safely follow up their patients with implanted cardioverter-defibrillators in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient follow-up and cost-savings for the health care payer. The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.

Conditions

• Ventricular Arrythmias

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-11-07
• Last updated: 2012-06-26

Locations

13 sites across 1 country: Germany