Full Text View
Tabular View
No Study Results Posted
Related Studies
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients (Monitor-ICD)
This study is currently recruiting participants.
Verified by Charite University, Berlin, Germany, October 2008
First Received: November 6, 2008   No Changes Posted
Sponsors and Collaborators: Charite University, Berlin, Germany
Biotronik GmbH & Co. KG
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00787683
  Purpose

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.


Condition Intervention
Ventricular Arrythmias
 Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Home-Monitoring in ICD Patients

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Comparison of disease specific costs from a societal perspective. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of shocks [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Hospital admissions [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Cardiac events [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Disease specific Costs from third party payers perspective [ Time Frame: up 24 months ] [ Designated as safety issue: No ]
  • Overall costs from societal and third party payers perspective [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 416
Study Start Date: October 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Home-monitoring: Experimental
Patients recieve 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.
Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II
All study participants recieve an ICD of the Biotronik lumax family. Only participants of the intervention group recieve 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 modiefied 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.
Standard care: No Intervention
Patients randomised to the standard care group recieve 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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787683

Contacts
Contact: Falk Müller-Riemenschneider, MD, MSc 004930450529036 falk.mueller-riemenschneider@charite.de

Locations
Germany
University Hospital Göttingen Recruiting
Göttingen, Germany, 37099
Contact: Markus Zabel, Prof., MD     00490551-39-10265     markus.zabel@med.uni-goettingen.de    
Principal Investigator: Markus Zabel            
Sub-Investigator: L Lüthje, MD            
University Hospital Münster Recruiting
Münster, Germany
Contact: Lars Eckardt, Prof., MD     00490251-8347687     eckardt@ukmuenster.de    
Principal Investigator: Lars Eckardt, Prof., MD            
Sub-Investigator: Julia Köbe            
Academic Teaching Hospital Villingen of the University of Freiburg Recruiting
Villingen-Schwenningen, Germany
Contact: Werner Jung, Prof., MD         werner.jung@sbk-vs.de    
Principal Investigator: Werner Jung, Prof., MD            
Hospital Bad Berka Recruiting
Bad Berka, Germany
Contact: Christoph Geller, Prof., MD     0049036458 - 51201     c.geller.kar@zentralklink-bad-berka.de    
Principal Investigator: Christoph Geller, Prof., MD            
Sub-Investigator: Grosse, MD            
Hospital Coburg Recruiting
Coburg, Germany
Contact: Johannes Brachmann, Prof., MD     004909561 22 63 98     johannes.brachmann@klinikum-coburg.de    
Principal Investigator: Johannes Brachmann, Prof., MD            
Sub-Investigator: Anil-Martin Sinha, MD            
Heart Centre Bodensee Konstanz Recruiting
Konstanz, Germany
Contact: Volker Kühlkamp, Prof., MD     004907531 897 112     volker.kuehlkamp@herz-zentrum.com    
Principal Investigator: Werner Kühlkamp, Prof., MD            
Sub-Investigator: Holger Stöckel, MD            
Sponsors and Collaborators
Charite University, Berlin, Germany
Biotronik GmbH & Co. KG
Investigators
Principal Investigator: Markus Zabel, Prof., MD Medical Faculty, University of Göttingen, Germany
  More Information

No publications provided

Responsible Party: Medical Faculty, University of Göttingen, Germany ( Prof. Dr. Markus Zabel )
Study ID Numbers: V6.2
Study First Received: November 6, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00787683     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Patients with ventricular arrhythmias and the prevention of sudden cardiac death

Study placed in the following topic categories:
Death
Heart Diseases
Death, Sudden, Cardiac
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services