NCT00989417

Brief Summary

In many aspects of every-day life, modern communication systems bring about a remarkable increase in comfort and safety by transmitting data and information in an easy and reliable manner. In order to provide these advantages also to patients with implantable cardioverter-defibrillators, as well as to their physicians, BIOTRONIK has developed a long-distance implant telemetry to enable periodic trend and event-triggered transmissions of implant data and intracardiac electrogram over distances of several meters. The data is received by a patient device and subsequently automatically transferred to a BIOTRONIK Service Center that provides it to the physician on a password secured internet site. Hence, the physician receives diagnostic information without the patient having to visit the physician (Home Monitoring, HM). New possibilities will arise for a detailed medical and event-correlated supervision of the patient's therapy using electrically active implants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
473

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

3.8 years

First QC Date

October 2, 2009

Last Update Submit

May 24, 2011

Conditions

Implantable Cardioverter-DefibrillatorsVentricular FibrillationTachycardia, Ventricular

Keywords

Remote monitoringDefibrillators, ImplantableHome monitoringShockImplantable cardioverter-defibrillator Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with more than one Significant Serious Adverse Event (SSAE) since home-monitoring activation. SSAE is a composite comprising all-cause mortality, cardiac or device related Serious Adverse Events

    27 months

Secondary Outcomes (5)

  • Total costs minimization analyse

    27 months

  • Delay of Home Monitoring to manage adverse events

    27 months

  • Sensitivity of Home Monitoring to detect ICD dysfunction

    27 months

  • Number of capacitor charge and incidence on ICD-battery longevity

    27 months

  • Difference of cardiac and device related Adverse Event

    27 Months

Study Arms (2)

CONTROL Group - Without Home Monitoring

ACTIVE COMPARATOR

Patients receiving the standard of care. Due to safety concerns, the patients are followed every 6 months after a first follow-up, which is performed between 1 and 3 months after implantation.

Other: ACTIVATION of HOME MONITORING

ACTIVE GROUP With Home Monitoring

EXPERIMENTAL

After a first follow-up (between 1 and 3 months after implantation), the patients are followed one time per year. Within this period, the additional ICD follow-up or therapeutic intervention will be primarily triggered on cardio-reports reception, Data/IEGM-online analysis on internet site or patient/physician call.

Other: ACTIVATION of HOME MONITORING

Interventions

ACTIVATION of HOME MONITORINGOTHER

Both patient groups will be followed for 27 months and will have Home Monitoring switched on. The data from the CONTROL group will not be presented online to the attending physician, but a retrospective analysis on differences between the two groups will be performed.

ACTIVE GROUP With Home MonitoringCONTROL Group - Without Home Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for single or dual chamber ICD

You may not qualify if:

  • NYHA class IV
  • Pregnant woman or woman who plan to become pregnant during the trial
  • Patient whose medical situation is not stable
  • Presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea \> 70mg/dl or creatinine \>3mg/dl), liver failure, etc.
  • Age \< 18 years
  • Patient unable to handle Home Monitoring system correctly
  • The patient is not willing and able to comply with the protocol
  • Change of residence expected during study
  • Insufficient GSM coverage at patient's home
  • Participation in another clinical study
  • Patient unwilling to sign the consent for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Lille- Hôpital Cardiologique

Lille, France

Location

Related Publications (3)

  • Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Kacet S; ECOST trial Investigators. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace. 2014 Aug;16(8):1181-8. doi: 10.1093/europace/euu012. Epub 2014 Mar 9.

    PMID: 24614572DERIVED

  • Guedon-Moreau L, Kouakam C, Klug D, Marquie C, Brigadeau F, Boule S, Blangy H, Lacroix D, Clementy J, Sadoul N, Kacet S. Decreased delivery of inappropriate shocks achieved by remote monitoring of ICD: a substudy of the ECOST trial. J Cardiovasc Electrophysiol. 2014 Jul;25(7):763-70. doi: 10.1111/jce.12405. Epub 2014 Apr 10.

    PMID: 24602062DERIVED

  • Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2013 Feb;34(8):605-14. doi: 10.1093/eurheartj/ehs425. Epub 2012 Dec 13.

    PMID: 23242192DERIVED

MeSH Terms

Conditions

Ventricular FibrillationTachycardia, VentricularShock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Study Officials

  • Salem S KACET, Prof. Dr.

    CHRU de Lille- Hôpital Cardiologique - F 59037Lille -FRANCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

January 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations

FR(1)