Ventricular Arrythmias
Conditions
Keywords
Patients with ventricular arrhythmias and the prevention of sudden cardiac death
Brief 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.
Interventions
DEVICEHome-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
Biotronik SE & Co. KG
F. Mueller-Riemenschneider
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of disease specific costs from a societal perspective. | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Hospital admissions | up to 24 months |
| Cardiac events | up to 24 months |
| Number of shocks | up to 24 months |
| Disease specific Costs from third party payers perspective | up 24 months |
| Overall costs from societal and third party payers perspective | up to 24 months |
| Quality of life | up to 24 months |
Countries
Germany
Outcome results
None listed