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European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT00776087
First received: October 17, 2008
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients 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:

  1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service.
  2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
  3. Compares the indicators of patients' safety between the two FU models.

Condition Intervention Phase
Ventricular Fibrillation
Tachycardia, Ventricular
Ventricular Flutter
Device: Home Monitoring provided by Biotronik ICD and CRT-D devices
Device: No Home Monitoring
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Euro spent to follow up ICD and CRT-D patients [ Time Frame: 26 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average number of in-hospital follow-up visits per patient [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Time to first in-hospital follow-up visit beyond the first post-implantation visit [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Effective financial impact on hospitals / physicians [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions) [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Incidence of inappropriate ICD shocks [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits [ Time Frame: 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 416
Study Start Date: July 2008
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 = Home Monitoring
Remote monitoring of ICD and CRT-D function and patient status
Device: Home Monitoring provided by Biotronik ICD and CRT-D devices
Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety
Active Comparator: 2 = No Home Monitoring
Home Monitoring option is switched off
Device: No Home Monitoring
Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).

Detailed Description:

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 and CRT-D 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-and CRT-D 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 and 104 patients with an indication for de novo CRT-D implantation should be enrolled. All patients will be implanted with BIOTRONIK ICD or CRT-D devices from the 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/CRT-D 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:

  • designated case report forms
  • a web-based time measurements software.

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 and CRT-D 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

ICD Patient Population - Inclusion Criteria

  • Indication for 1-/2- chamber ICD implantation, including replacement indication
  • Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent

ICD Patient Population - Exclusion Criteria

  • Patients with contraindication to ICD implantation
  • Patients with indication for cardiac resynchronization (CRT)
  • Minors and pregnant women
  • Patients participating in another study

CRT-D Patient Population - Inclusion Criteria

  • Patients with indication for de novo CRT-D implantation according to current guidelines
  • Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent

CRT-D Patient Population - Exclusion Criteria

  • Patients who had a cardiac device implanted before (upgrade, device replacement)
  • Life expectancy less than 12 months
  • Planned heart transplantation
  • NYHA IV
  • Minors < 18 years
  • Pregnant and breast-feeding women
  • Participation in another clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776087

Contacts
Contact: Sascha Mrosk +49 (0) 30 68905 ext 1308 sascha.mrosk@biotronik.com
Contact: Jochen Proff +49 (0) 151 1631 ext 7810 jochen.proff@biotronik.com

Locations
Belgium
Heart Rhythm Management Institute, Free University of Brussels Terminated
Brussels, Belgium
Ziekenhuis Oost Limburg, Campus St. Jan Recruiting
Genk, Belgium
Principal Investigator: Maximo Rivero-Ayerza, Dr.         
Jessa Ziekenhuis (Campus Virga Jesse) Recruiting
Hasselt, Belgium
Principal Investigator: Johan Vijgen, Dr.         
ZU Gasthuisberg Recruiting
Leuven, Belgium
Principal Investigator: Hein Heidbüchel, Prof. Dr.         
Finland
University of Oulu Active, not recruiting
Oulu, Finland, 90014
Germany
Helios Klinikum Aue Recruiting
Aue, Germany, 08280
Principal Investigator: Klaus Malinowski, MD         
Charité Berlin Campus Mitte Recruiting
Berlin, Germany, 10117
Principal Investigator: Andrea Marek, Dr. med.         
Herzzentrum Leipzig, Abteilung Rhythmologie Recruiting
Leipzig, Germany
Principal Investigator: Gerhard Hindricks, Prof. Dr. med.         
Städt. Klinikum St. Georg gGmbH Active, not recruiting
Leipzig, Germany, 04129
Netherlands
Leiden Universitair Medisch Centrum Recruiting
Leiden, Netherlands, 2333
Principal Investigator: Liselot van Erven, Dr.         
Spain
Hospital Universitario La Paz Active, not recruiting
La Paz, Spain
Hospital Universitario Puerta de Hierro Majadahonda Active, not recruiting
Madrid, Spain
Hospital Ntra.Sra.de la Candelaria Recruiting
Tenerife, Spain
Principal Investigator: Rafael Romero, Dr.         
Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral) Recruiting
Vigo, Spain
Principal Investigator: Julio Beiras Torrado, Dr.         
United Kingdom
Cardiology, Aberdeen Royal Infirmary Active, not recruiting
Aberdeen, United Kingdom
Cardiology, St. Peters Hospital/St. George's Active, not recruiting
Chertsey, United Kingdom
Cardiology; Raigmore Hospital Active, not recruiting
Inverness, United Kingdom
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Hein Heidbüchel, Prof. Dr. ZU Gasthuisberg, Leuven, Belgium
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT00776087     History of Changes
Other Study ID Numbers: HS043
Study First Received: October 17, 2008
Last Updated: August 1, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Medical costs
Telemonitoring
Implantable cardioverter-defibrillator

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Ventricular Flutter
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014