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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Arrythmias||Device: Home-monitoring provided by LUMAX ICD device and CardioMessenger II||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home-Monitoring in ICD Patients|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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.
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.
- Comparison of disease specific costs from a societal perspective. [ Time Frame: up to 24 months ]
- Number of shocks [ Time Frame: up to 24 months ]
- Hospital admissions [ Time Frame: up to 24 months ]
- Cardiac events [ Time Frame: up to 24 months ]
- Quality of life [ Time Frame: up to 24 months ]
- Disease specific Costs from third party payers perspective [ Time Frame: up 24 months ]
- Overall costs from societal and third party payers perspective [ Time Frame: up to 24 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00787683
|Bremerhaven, Niedersachsen, Germany, 27574|
|Hannover, Niedersachsen, Germany, 30625|
|University Hospital Aachen|
|Aachen, Nordrhein-Westfalen, Germany, 52074|
|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|
|University Hospital Göttingen|
|Göttingen, Germany, 37099|
|Asklepios Hospital Barmbeck in Hamburg|
|Hamburg, Germany, 22291|
|Heart Centre Bodensee Konstanz|
|University Hospital Münster|
|Academic Teaching Hospital Villingen of the University of Freiburg|
|Principal Investigator:||Markus Zabel, Prof., MD||Medical Faculty, University of Göttingen, Germany|