Overview

This trial is active, not recruiting.

Condition ventricular arrythmias
Treatment home-monitoring provided by lumax icd device and cardiomessenger ii
Sponsor F. Mueller-Riemenschneider
Collaborator Biotronik SE & Co. KG
Start date October 2008
End date December 2012
Trial size 416 participants
Trial identifier NCT00787683, V7.0

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive an additional home-monitoring (remote-monitoring) device (CardioMessengerII) following Biotronik Lumax ICD implantation. The device enables regular transmission and examination of ICD information via home-monitoring. Follow-up appointments in outpatient clinic are changed compared to standard care. While follow-up 1, 12, and 24 months after ICD implantation consist of outpatient clinic appointments, follow-up 3, 6, and 18 months after ICD implantation are conducted remotely.
home-monitoring provided by lumax icd device and cardiomessenger ii Home-monitoring
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.
(No Intervention)
Patients randomised to the standard care group receive no home-monitoring device (CardioMessengerII) following Lumax ICD implantation. Patients have scheduled follow-up appointments at the ICD outpatient clinics at 1, 3, 6, 12, 18, and 24 months after ICD implantation.

Primary Outcomes

Measure
Comparison of disease specific costs from a societal perspective.
time frame: up to 24 months

Secondary Outcomes

Measure
Number of shocks
time frame: up to 24 months
Hospital admissions
time frame: up to 24 months
Cardiac events
time frame: up to 24 months
Quality of life
time frame: up to 24 months
Disease specific Costs from third party payers perspective
time frame: up 24 months
Overall costs from societal and third party payers perspective
time frame: up to 24 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - The patient is willing/able to undergo the study protocol appointments and procedures/questionnaires - Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines Exclusion Criteria: - Age < 18 and > 80 years - Expected non-compliance - Known drug or alcohol abuse - Life expectancy < 1 year - NYHA classification IV - Participation in another clinical study - Participation in another telemonitoring concept - Pregnant or breast-feeding woman - Uncontrolled hypertension - No mobile phone use possible in patient residence

Additional Information

Official title Home-Monitoring in ICD Patients
Principal investigator Markus Zabel, Prof., MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Charite University, Berlin, Germany.