Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients (Monitor-ICD)
June 25, 2012 updated by: F. Mueller-Riemenschneider
Home-Monitoring in ICD Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
416
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bad Berka, Germany
- Hospital Bad Berka
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Coburg, Germany
- Hospital Coburg
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Göttingen, Germany, 37099
- University Hospital Göttingen
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Hamburg, Germany, 22291
- Asklepios Hospital Barmbeck in Hamburg
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Konstanz, Germany
- Heart Centre Bodensee Konstanz
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Münster, Germany
- University Hospital Munster
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Villingen-Schwenningen, Germany
- Academic Teaching Hospital Villingen of the University of Freiburg
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Niedersachsen
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Bremerhaven, Niedersachsen, Germany, 27574
- Hospital Bremerhaven
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Hannover, Niedersachsen, Germany, 30625
- MH-Hannover
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Nordrhein-Westfalen
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Aachen, Nordrhein-Westfalen, Germany, 52074
- University Hospital Aachen
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Bonn, Nordrhein-Westfalen, Germany, 53127
- Cardiological Practice
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Paderborn, Nordrhein-Westfalen, Germany, 33098
- St. Vincenz Hospital Paderborn
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- University Hospital Schleswig-Holstein
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Comparison of disease specific costs from a societal perspective.
Time Frame: up to 24 months
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Number of shocks
Time Frame: up to 24 months
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up to 24 months
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Hospital admissions
Time Frame: up to 24 months
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up to 24 months
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Cardiac events
Time Frame: up to 24 months
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up to 24 months
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Quality of life
Time Frame: up to 24 months
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up to 24 months
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Disease specific Costs from third party payers perspective
Time Frame: up 24 months
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up 24 months
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Overall costs from societal and third party payers perspective
Time Frame: up to 24 months
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up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Markus Zabel, Prof., MD, Medical Faculty, University of Göttingen, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
November 6, 2008
First Submitted That Met QC Criteria
November 6, 2008
First Posted (Estimate)
November 7, 2008
Study Record Updates
Last Update Posted (Estimate)
June 26, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V7.0
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