Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
Monitor-ICD
Home-Monitoring in ICD Patients
1 other identifier
interventional
416
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 6, 2008
CompletedFirst Posted
Study publicly available on registry
November 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 26, 2012
June 1, 2012
4.2 years
November 6, 2008
June 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of disease specific costs from a societal perspective.
up to 24 months
Secondary Outcomes (6)
Number of shocks
up to 24 months
Hospital admissions
up to 24 months
Cardiac events
up to 24 months
Quality of life
up to 24 months
Disease specific Costs from third party payers perspective
up 24 months
- +1 more secondary outcomes
Study Arms (2)
Home-monitoring
EXPERIMENTALPatients 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.
Standard care
NO INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- F. Mueller-Riemenschneiderlead
- Biotronik SE & Co. KGcollaborator
Study Sites (13)
Asklepios Hospital Barmbeck in Hamburg
Hamburg, Hamburg, 22291, Germany
Hospital Bremerhaven
Bremerhaven, Lower Saxony, 27574, Germany
MH-Hannover
Hanover, Lower Saxony, 30625, Germany
University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Cardiological Practice
Bonn, North Rhine-Westphalia, 53127, Germany
St. Vincenz Hospital Paderborn
Paderborn, North Rhine-Westphalia, 33098, Germany
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Hospital Bad Berka
Bad Berka, Germany
Hospital Coburg
Coburg, Germany
University Hospital Göttingen
Göttingen, 37099, Germany
Heart Centre Bodensee Konstanz
Konstanz, Germany
University Hospital Münster
Münster, Germany
Academic Teaching Hospital Villingen of the University of Freiburg
Villingen-Schwenningen, Germany
Related Publications (1)
Zabel M, Muller-Riemenschneider F, Geller JC, Brachmann J, Kuhlkamp V, Dissmann R, Reinhold T, Roll S, Luthje L, Bode F, Eckardt L, Willich SN; MONITOR-ICD investigators. Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators. Am Heart J. 2014 Oct;168(4):430-7. doi: 10.1016/j.ahj.2014.04.021. Epub 2014 Jun 13.
PMID: 25262251DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Zabel, Prof., MD
Medical Faculty, University of Göttingen, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PD, Dr.
Study Record Dates
First Submitted
November 6, 2008
First Posted
November 7, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-06