Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
- Conditions
- Ventricular Arrythmias
- Interventions
- Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II
- Registration Number
- NCT00787683
- Lead Sponsor
- F. Mueller-Riemenschneider
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 416
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-monitoring Home-monitoring provided by LUMAX ICD device and CardioMessenger II 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.
- Primary Outcome Measures
Name Time Method Comparison of disease specific costs from a societal perspective. up to 24 months
- Secondary Outcome Measures
Name Time Method Disease specific Costs from third party payers perspective up 24 months 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 Overall costs from societal and third party payers perspective up to 24 months
Trial Locations
- Locations (13)
University Hospital Schleswig-Holstein
🇩🇪Lübeck, Schleswig-Holstein, Germany
Hospital Bremerhaven
🇩🇪Bremerhaven, Niedersachsen, Germany
MH-Hannover
🇩🇪Hannover, Niedersachsen, Germany
St. Vincenz Hospital Paderborn
🇩🇪Paderborn, Nordrhein-Westfalen, Germany
Hospital Coburg
🇩🇪Coburg, Germany
University Hospital Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Cardiological Practice
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Hospital Bad Berka
🇩🇪Bad Berka, Germany
Heart Centre Bodensee Konstanz
🇩🇪Konstanz, Germany
Asklepios Hospital Barmbeck in Hamburg
🇩🇪Hamburg, Germany
University Hospital Münster
🇩🇪Münster, Germany
University Hospital Göttingen
🇩🇪Göttingen, Germany
Academic Teaching Hospital Villingen of the University of Freiburg
🇩🇪Villingen-Schwenningen, Germany