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

Ventricular Fibrillation Clinical Trial

— EuroEco  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776087
• Other study ID #: HS043
• Status: Terminated
• Phase: N/A
• First received: October 17, 2008
• Last updated: June 29, 2017
• Start date: October 17, 2008
• Est. completion date: October 27, 2016

Study information

• Verified date: June 2017
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 409
• Est. completion date: October 27, 2016
• Est. primary completion date: July 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Flutter

Intervention

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
• No Home Monitoring
Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).

Locations

Country	Name	City	State
Belgium	Heart Rhythm Management Institute, Free University of Brussels	Brussels
Belgium	Ziekenhuis Oost Limburg, Campus St. Jan	Genk
Belgium	Jessa Ziekenhuis (Campus Virga Jesse)	Hasselt
Belgium	ZU Gasthuisberg	Leuven
Finland	University of Oulu	Oulu
Germany	Helios Klinikum Aue	Aue
Germany	Charité Berlin Campus Mitte	Berlin
Germany	Herzzentrum Leipzig, Abteilung Rhythmologie	Leipzig
Germany	Städt. Klinikum St. Georg gGmbH	Leipzig
Netherlands	Leiden Universitair Medisch Centrum	Leiden
Spain	Hospital Universitario La Paz	La Paz
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Ntra.Sra.de la Candelaria	Tenerife
Spain	Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral)	Vigo
United Kingdom	Cardiology, Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Cardiology, St. Peters Hospital/St. George's	Chertsey
United Kingdom	Cardiology; Raigmore Hospital	Inverness

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Belgium,  Finland,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Euro spent to follow up ICD and CRT-D patients		26 months
Secondary	Average number of in-hospital follow-up visits per patient		26 months
Secondary	Time to first in-hospital follow-up visit beyond the first post-implantation visit		12 months
Secondary	Effective financial impact on hospitals / physicians		26 months
Secondary	Proportion of in-hospital consultations with relevant findings (i.e. necessitating changes in medical therapy, device programming or re-hospitalisations/ interventions)		26 months
Secondary	Proportion of patients with HM-triggered interventions that, without remote monitoring, would have first been discovered at a subsequent scheduled follow-up		26 months
Secondary	Incidence of inappropriate ICD shocks		26 months
Secondary	Changes in quality-of-life (SF-36) from baseline to the 12- and to 24-month follow-up visits		26 months