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Sponsored by: |
Biotronik GmbH & Co. KG |
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Information provided by: | Biotronik GmbH & Co. KG |
ClinicalTrials.gov Identifier: | NCT00776087 |
BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their patients with implanted cardioverter-defibrillators (ICDs) in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer.
The EuroEco study:
Condition | Intervention | Phase |
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Ventricular Fibrillation Tachycardia, Ventricular Ventricular Flutter |
Device: Home Monitoring provided by single- or dual-chamber ICD devices from the Lumos and Lumax families (BIOTRONIK) Device: No Home Monitoring |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | European Health Economic Trial on Home Monitoring in ICD Therapy (EuroEco) |
Estimated Enrollment: | 312 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 = Home Monitoring: Experimental
Remote monitoring of ICD function and patient status
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Device: Home Monitoring provided by single- or dual-chamber ICD devices from the Lumos and Lumax families (BIOTRONIK)
Remote monitoring of ICD function and patient status may result in more effective follow-up and increased patient safety
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2 = No Home Monitoring: Active Comparator
Home Monitoring option is switched off
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Device: No Home Monitoring
Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).
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The EuroEco is a prospective, international, randomized study aimed at assessing the economic effects of BIOTRONIK Home Monitoring (HM) technology as compared with traditional follow up (FU) of ICD patients from two perspectives: 1) the cost-effectiveness for the payer of health care, and 2) the economic impact on the physician, hospital and patient. The study outlines a new model for the FU of ICD-patients based on a combination of in-clinic consultations and regular check ups of the patient data received through the HM service.
About 312 patients with an indication for ICD therapy should be enrolled. All patients will be implanted with BIOTRONIK single- or dual-chamber ICD devices from the Lumos and Lumax families and randomized (1:1) to the traditional, or to HM-based FU model. Traditional FU will be performed according to the local clinical practice. Patients in the HM study arm will first undergo local clinical FU routine until the first in-clinic visit after patient discharge. Thereafter routine in-clinic FUs are scheduled at 12 and 24 months. Three HM data checks should be carried out during each 12-month interval, to assess the patient/ICD status remotely.
In both (HM and no HM) groups, additional in-hospital FU may be scheduled any time the patients reports symptoms which are presumed to be cardiovascular symptoms. In the HM group, additional in-clinic FU may also be scheduled as a result of specific HM findings.
The following FU-related activities were accounted for: in-clinic consultations, patients contact, discussion with colleague physician, nurse or technician and arranging in clinic consultation. In HM patients, two additional HM-related FU activities were taken into account: 1) checking the website of BIOTRONIK HM Service Center, and 2) checking HM-related emails and faxes (provided by BIOTRONIK HM Service Center)..
Several tools were made available to document the time that physicians, nurses and technicians spend with these FU activities without disrupting their clinical routine much:
A user manual for time measurements was handed out to physicians, nurses and technicians to recommend which tool should be used in which clinical situation. The average time per patient followed according to the traditional FU model and the average time per patient followed by the HM-based FU model will be calculated for each of the three health care professionals considered (physicians, nurses and technicians). The difference in costs between the traditional and the HM-based FU will be assessed for statistical significance.
This trial may provide data warranting a change in the guidelines for the use of ICD devices featuring HM function, in that HM may justify a prolongation of the time interval between statutory routine in-clinic FU visits. Coupled with the fact that the information provided by HM helps physicians to recognize some otherwise unsuspected needs for additional FU visits, this may ultimately result in better and more cost-effective health care for all parts involved (patients, providers and payers).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Corina Nitz, MD | +49 (0) 9131 8924 7825 | corina.nitz@biotronik.com |
Contact: Petra Maier, PhD | +49 (0) 9131 8924 7820 | petra.maier@biotronik.com |
Belgium | |
Heart Rhythm Management Institute, Free University of Brussels | Recruiting |
Brussels, Belgium | |
Principal Investigator: Pedro Brugada, Prof. Dr. | |
Ziekenhuis Oost Limburg, Campus St. Jan | Recruiting |
Genk, Belgium | |
Principal Investigator: Maximo Rivero-Ayerza, Dr. | |
ZU Gasthuisberg | Recruiting |
Leuven, Belgium | |
Principal Investigator: Hein Heidbüchel, Prof. Dr. | |
Germany | |
Klinik für Innere Medizin - Abteilung 1, Städtische Kliniken Frankfurt am Main - Höchst | Not yet recruiting |
Frankfurt am Main, Germany | |
Principal Investigator: Semis Sen, Prof. Dr. | |
Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm | Not yet recruiting |
Wittenberg, Germany | |
Principal Investigator: Gerhard Hoh, Dr. | |
Uniklinikum Rostock, Medizinische Fakultät, Klinik und Poliklinik für Innere Medizin | Not yet recruiting |
Rostock, Germany | |
Principal Investigator: Dietmar Bänsch, Dr. | |
Spain | |
Hospital Ntra.Sra.de la Candelaria | Not yet recruiting |
Tenerife, Spain | |
Principal Investigator: Rafael Romero, Dr. | |
Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral) | Not yet recruiting |
Vigo, Spain | |
Principal Investigator: Julio Beiras Torrado, Dr. | |
United Kingdom | |
Cardiology, Aberdeen Royal Infirmary | Not yet recruiting |
Aberdeen, United Kingdom | |
Principal Investigator: Paul Broadhurst, Dr. | |
Cardiology, St. Peters Hospital/St. George's | Not yet recruiting |
Chertsey, United Kingdom | |
Principal Investigator: Vince Paul, Dr. | |
Cardiology; Raigmore Hospital | Not yet recruiting |
Inverness, United Kingdom | |
Principal Investigator: Stephen Cross, Dr. |
Study Chair: | Hein Heidbüchel, Prof. Dr. | ZU Gasthuisberg, Leuven, Belgium |
Responsible Party: | Organization: Biotronik GmbH & Co.KG ( Dr. Corina Nitz ) |
Study ID Numbers: | HS043 |
Study First Received: | October 17, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00776087 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Medical costs Telemonitoring Implantable cardioverter-defibrillator |
Heart Diseases Tachycardia Paroxysmal ventricular fibrillation Ventricular Flutter |
Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |