Home-Monitoring in ICD Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 416
- Locations
- 13
- Primary Endpoint
- Comparison of disease specific costs from a societal perspective.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Home-monitoring
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.
Intervention: Home-monitoring provided by LUMAX ICD device and CardioMessenger II (Device)
Standard care
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.
Outcomes
Primary Outcomes
Comparison of disease specific costs from a societal perspective.
Time Frame: up to 24 months
Secondary Outcomes
- Number of shocks(up to 24 months)
- Hospital admissions(up to 24 months)
- Cardiac events(up to 24 months)
- Quality of life(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)
Investigators
F. Mueller-Riemenschneider
PD, Dr.
Charite University, Berlin, Germany