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

NCT00776087 | Terminated

• 1 other identifier: HS043
• Study Type: interventional
• Target: 409
• Locations: 6 countries
• Sites: 17

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:

1. 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. 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. 3.Compares the indicators of patients' safety between the two FU models.

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular; Ventricular Flutter

Keywords

Medical costs; Telemonitoring; Implantable cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

• Euro spent to follow up ICD and CRT-D patients

  26 months

Secondary Outcomes (7)

• 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

Study Arms (2)

1 = Home Monitoring

EXPERIMENTAL

Remote monitoring of ICD and CRT-D function and patient status

Device: Home Monitoring provided by Biotronik ICD and CRT-D devices

2 = No Home Monitoring

ACTIVE COMPARATOR

Home Monitoring option is switched off

Device: No Home Monitoring

Interventions

Home Monitoring provided by Biotronik ICD and CRT-D devices DEVICE

Remote monitoring of ICD and CRT-D function and patient status may result in more effective follow-up and increased patient safety

1 = Home Monitoring

No Home Monitoring DEVICE

Home Monitoring option is switched off (in the same kind of devices as used in the other study arm).

2 = No Home Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (17)

Heart Rhythm Management Institute, Free University of Brussels

Brussels, Belgium

Location

Ziekenhuis Oost Limburg, Campus St. Jan

Genk, Belgium

Location

Jessa Ziekenhuis (Campus Virga Jesse)

Hasselt, Belgium

Location

ZU Gasthuisberg

Leuven, Belgium

Location

University of Oulu

Oulu, 90014, Finland

Location

Helios Klinikum Aue

Aue, 08280, Germany

Location

Charité Berlin Campus Mitte

Berlin, 10117, Germany

Location

Städt. Klinikum St. Georg gGmbH

Leipzig, 04129, Germany

Location

Herzzentrum Leipzig, Abteilung Rhythmologie

Leipzig, Germany

Location

Leiden Universitair Medisch Centrum

Leiden, 2333, Netherlands

Location

Hospital Universitario La Paz

La Paz, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Ntra.Sra.de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Arrythmia Unit, Complejo Hospitalario de Vigo (Hospital Xeral)

Vigo, Spain

Location

Cardiology, Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Cardiology, St. Peters Hospital/St. George's

Chertsey, United Kingdom

Location

Cardiology; Raigmore Hospital

Inverness, United Kingdom

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular; Ventricular Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Hein Heidbüchel, Prof. Dr.

  ZU Gasthuisberg, Leuven, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: HM ON vs. HM OFF
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized prospective multicenter international clinical trial

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: October 17, 2008
• Primary Completion: July 21, 2016
• Study Completion: October 27, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); DE (4); FI (1); BE (4); ES (4); GB (3)