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

Sponsor

Biotronik SE & Co. KG (Industry)

Overall Status

Terminated

CT.gov ID

NCT00776087

Collaborator

(none)

409

Enrollment

Locations

Arms

96.3

Actual Duration (Months)

24.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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.
Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU.
Compares the indicators of patients' safety between the two FU models.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Fibrillation Tachycardia, Ventricular Ventricular Flutter	Device: Home Monitoring provided by Biotronik ICD and CRT-D devices Device: No Home Monitoring	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

409 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized prospective multicenter international clinical trialRandomized prospective multicenter international clinical trial

Masking:

None (Open Label)

Masking Description:

HM ON vs. HM OFF

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 17, 2008

Actual Primary Completion Date :

Jul 21, 2016

Actual Study Completion Date :

Oct 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

Euro spent to follow up ICD and CRT-D patients [26 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Heart Rhythm Management Institute, Free University of Brussels	Brussels	Belgium
2	Ziekenhuis Oost Limburg, Campus St. Jan	Genk	Belgium
3	Jessa Ziekenhuis (Campus Virga Jesse)	Hasselt	Belgium
4	ZU Gasthuisberg	Leuven	Belgium
5	University of Oulu	Oulu	Finland	90014
6	Helios Klinikum Aue	Aue	Germany	08280
7	Charité Berlin Campus Mitte	Berlin	Germany	10117
8	Städt. Klinikum St. Georg gGmbH	Leipzig	Germany	04129
9	Herzzentrum Leipzig, Abteilung Rhythmologie	Leipzig	Germany
10	Leiden Universitair Medisch Centrum	Leiden	Netherlands	2333
11	Hospital Universitario La Paz	La Paz	Spain
12	Hospital Universitario Puerta de Hierro Majadahonda	Madrid	Spain
13	Hospital Ntra.Sra.de la Candelaria	Tenerife	Spain
14	Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral)	Vigo	Spain
15	Cardiology, Aberdeen Royal Infirmary	Aberdeen	United Kingdom
16	Cardiology, St. Peters Hospital/St. George's	Chertsey	United Kingdom
17	Cardiology; Raigmore Hospital	Inverness	United Kingdom