Clinical trial NCT00787683: Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
Official title: Home-Monitoring in ICD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Arrythmias
Keywords: Patients with ventricular arrhythmias and the prevention of sudden cardiac death
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2008-11-07
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of disease specific costs from a societal perspective.
timeFrame: up to 24 months
Secondary outcomes:
measure: Number of shocks
timeFrame: up to 24 months
measure: Hospital admissions
timeFrame: up to 24 months
measure: Cardiac events
timeFrame: up to 24 months
measure: Quality of life
timeFrame: up to 24 months
measure: Disease specific Costs from third party payers perspective
timeFrame: up 24 months
measure: Overall costs from societal and third party payers perspective
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bremerhaven
country: Germany
facility: Hospital Bremerhaven
state: Niedersachsen
city: Hannover
country: Germany
facility: MH-Hannover
state: Niedersachsen
city: Aachen
country: Germany
facility: University Hospital Aachen
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Cardiological Practice
state: Nordrhein-Westfalen
city: Paderborn
country: Germany
facility: St. Vincenz Hospital Paderborn
state: Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: University Hospital Schleswig-Holstein
state: Schleswig-Holstein
city: Bad Berka
country: Germany
facility: Hospital Bad Berka
city: Coburg
country: Germany
facility: Hospital Coburg
city: Göttingen
country: Germany
facility: University Hospital Göttingen
city: Hamburg
country: Germany
facility: Asklepios Hospital Barmbeck in Hamburg
city: Konstanz
country: Germany
facility: Heart Centre Bodensee Konstanz
city: Münster
country: Germany
facility: University Hospital Münster
city: Villingen-Schwenningen
country: Germany
facility: Academic Teaching Hospital Villingen of the University of Freiburg
Study officials:
affiliation: Medical Faculty, University of Göttingen, Germany
name: Markus Zabel, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.