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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-monitoring | 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. |
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| Standard care | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-monitoring provided by LUMAX ICD device and CardioMessenger II | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of disease specific costs from a societal perspective. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of shocks | up to 24 months | |
| Hospital admissions | up to 24 months | |
| Cardiac events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Zabel, Prof., MD | Medical Faculty, University of Göttingen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepios Hospital Barmbeck in Hamburg | Hamburg | Free and Hanseatic City of Hamburg | 22291 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25262251 | Derived | Zabel M, Muller-Riemenschneider F, Geller JC, Brachmann J, Kuhlkamp V, Dissmann R, Reinhold T, Roll S, Luthje L, Bode F, Eckardt L, Willich SN; MONITOR-ICD investigators. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators. Am Heart J. 2014 Oct;168(4):430-7. doi: 10.1016/j.ahj.2014.04.021. Epub 2014 Jun 13. |
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| 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 |
| Hospital Bremerhaven |
| Bremerhaven |
| Lower Saxony |
| 27574 |
| Germany |
| MH-Hannover | Hanover | Lower Saxony | 30625 | Germany |
| University Hospital Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Cardiological Practice | Bonn | North Rhine-Westphalia | 53127 | Germany |
| St. Vincenz Hospital Paderborn | Paderborn | North Rhine-Westphalia | 33098 | Germany |
| University Hospital Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Hospital Bad Berka | Bad Berka | Germany |
| Hospital Coburg | Coburg | Germany |
| University Hospital Göttingen | Göttingen | 37099 | Germany |
| Heart Centre Bodensee Konstanz | Konstanz | Germany |
| University Hospital Münster | Münster | Germany |
| Academic Teaching Hospital Villingen of the University of Freiburg | Villingen-Schwenningen | Germany |