Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients

Ventricular Arrythmias Clinical Trial

— Monitor-ICD  

Official title:

Home-Monitoring in ICD Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00787683
• Other study ID #: V7.0
• Status: Active, not recruiting
• Phase: N/A
• First received: November 6, 2008
• Last updated: June 25, 2012
• Start date: October 2008
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 416
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ventricular Arrythmias

Intervention

Device:
• Home-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.

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen	Nordrhein-Westfalen
Germany	Hospital Bad Berka	Bad Berka
Germany	Cardiological Practice	Bonn	Nordrhein-Westfalen
Germany	Hospital Bremerhaven	Bremerhaven	Niedersachsen
Germany	Hospital Coburg	Coburg
Germany	University Hospital Göttingen	Göttingen
Germany	Asklepios Hospital Barmbeck in Hamburg	Hamburg
Germany	MH-Hannover	Hannover	Niedersachsen
Germany	Heart Centre Bodensee Konstanz	Konstanz
Germany	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	University Hospital Münster	Münster
Germany	St. Vincenz Hospital Paderborn	Paderborn	Nordrhein-Westfalen
Germany	Academic Teaching Hospital Villingen of the University of Freiburg	Villingen-Schwenningen

Sponsors (2)

Lead Sponsor	Collaborator
F. Mueller-Riemenschneider	Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of disease specific costs from a societal perspective.		up to 24 months	No
Secondary	Number of shocks		up to 24 months	Yes
Secondary	Hospital admissions		up to 24 months	Yes
Secondary	Cardiac events		up to 24 months	Yes
Secondary	Quality of life		up to 24 months	No
Secondary	Disease specific Costs from third party payers perspective		up 24 months	No
Secondary	Overall costs from societal and third party payers perspective		up to 24 months	No