Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients (Monitor-ICD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787683
Recruitment Status : Unknown
Verified June 2012 by F. Mueller-Riemenschneider, Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2008
Last Update Posted : June 26, 2012
Biotronik SE & Co. KG
Information provided by (Responsible Party):
F. Mueller-Riemenschneider, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Ventricular Arrythmias Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-Monitoring in ICD Patients
Study Start Date : October 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Home-monitoring
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.
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.
Other Names:
  • Home-monitoring
  • Remote-monitoring
  • Tele-monitoring
  • ICD
  • Biotronik
  • Lumax
  • CardioMessenger
No Intervention: Standard care
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.

Primary Outcome Measures :
  1. Comparison of disease specific costs from a societal perspective. [ Time Frame: up to 24 months ]

Secondary Outcome Measures :
  1. Number of shocks [ Time Frame: up to 24 months ]
  2. Hospital admissions [ Time Frame: up to 24 months ]
  3. Cardiac events [ Time Frame: up to 24 months ]
  4. Quality of life [ Time Frame: up to 24 months ]
  5. Disease specific Costs from third party payers perspective [ Time Frame: up 24 months ]
  6. Overall costs from societal and third party payers perspective [ Time Frame: up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787683

Hospital Bremerhaven
Bremerhaven, Niedersachsen, Germany, 27574
Hannover, Niedersachsen, Germany, 30625
University Hospital Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Cardiological Practice
Bonn, Nordrhein-Westfalen, Germany, 53127
St. Vincenz Hospital Paderborn
Paderborn, Nordrhein-Westfalen, Germany, 33098
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Hospital Bad Berka
Bad Berka, Germany
Hospital Coburg
Coburg, Germany
University Hospital Göttingen
Göttingen, Germany, 37099
Asklepios Hospital Barmbeck in Hamburg
Hamburg, Germany, 22291
Heart Centre Bodensee Konstanz
Konstanz, Germany
University Hospital Münster
Münster, Germany
Academic Teaching Hospital Villingen of the University of Freiburg
Villingen-Schwenningen, Germany
Sponsors and Collaborators
F. Mueller-Riemenschneider
Biotronik SE & Co. KG
Principal Investigator: Markus Zabel, Prof., MD Medical Faculty, University of Göttingen, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: F. Mueller-Riemenschneider, PD, Dr., Charite University, Berlin, Germany Identifier: NCT00787683     History of Changes
Other Study ID Numbers: V7.0
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

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