Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
NCT ID: NCT00787683
Last Updated: 2012-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
416 participants
INTERVENTIONAL
2008-10-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring
NCT00989417
Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients
NCT01230073
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
NCT00538356
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
NCT01594112
Clinical and Device Functional Assessment of Real World ICD Patients
NCT02341768
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The objective of the current study is to investigate the cost-effectiveness and effectiveness of home-monitoring compared to standard care.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Indication for implantation of single chamber ICD or dual chamber ICD according to European guidelines
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik SE & Co. KG
INDUSTRY
F. Mueller-Riemenschneider
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
F. Mueller-Riemenschneider
PD, Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Markus Zabel, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Medical Faculty, University of Göttingen, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Asklepios Hospital Barmbeck in Hamburg
Hamburg, City state of Hamburg, Germany
Hospital Bremerhaven
Bremerhaven, Lower Saxony, Germany
MH-Hannover
Hanover, Lower Saxony, Germany
University Hospital Aachen
Aachen, North Rhine-Westphalia, Germany
Cardiological Practice
Bonn, North Rhine-Westphalia, Germany
St. Vincenz Hospital Paderborn
Paderborn, North Rhine-Westphalia, Germany
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Hospital Bad Berka
Bad Berka, , Germany
Hospital Coburg
Coburg, , Germany
University Hospital Göttingen
Göttingen, , Germany
Heart Centre Bodensee Konstanz
Konstanz, , Germany
University Hospital Münster
Münster, , Germany
Academic Teaching Hospital Villingen of the University of Freiburg
Villingen-Schwenningen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V7.0
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.