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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
F. Mueller-Riemenschneider, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00787683
First received: November 6, 2008
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-Monitoring in ICD Patients

Resource links provided by NLM:

U.S. FDA Resources

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: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Locations
Germany
Hospital Bremerhaven
Bremerhaven, Niedersachsen, Germany, 27574
MH-Hannover
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
Investigators
Principal Investigator: Markus Zabel, Prof., MD Medical Faculty, University of Göttingen, Germany
  More Information

No publications provided

Responsible Party: F. Mueller-Riemenschneider, PD, Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00787683     History of Changes
Other Study ID Numbers: V7.0
Study First Received: November 6, 2008
Last Updated: June 25, 2012
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

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

ClinicalTrials.gov processed this record on May 23, 2013