Research with human participants

Overview of medical research in the Netherlands

European registry for ICD and CRT devices in pediatrics and adults with congenital heart disease (Euripides registry)

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European registry of children and patients with congenital heart disease that undergo ICD or CRT implantation. This will lead to a larger amount of data leading to increased knowledge about long-term consequences and potential complications.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Congenital cardiac disorders
Study type
Observational non invasive

ID

NL-OMON32025

Source

ToetsingOnline

Brief title

Registration of ICD and CRT devices

Condition

  • Congenital cardiac disorders
  • Cardiac and vascular disorders congenital

Synonym

rhythm disturbance'; syncope

Research involving

Human

Sponsors and support

Primary sponsor :
Leids Universitair Medisch Centrum
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
Cardiac Resynchronization Therapy, Congenital Heart Disease, Internal Cardiac Defibrillator

Outcome measures

Primary outcome

Number of ICD shocks

Complications

Battery life of ICD and CRT

Secondary outcome

NVT

Background summary

Patients with life-threatening rhythm disturbances or severe heart failure are
candidates for implantation of an internal cardioverter defibrillator (ICD) or
cardiac resynchronisation therapy device (CRT). Children and patients with
congenital heart disease, however, relatively infrequent undergo ICD or CRT
implantation. Therefore, knowledge about long-term consequences and potential
complications of these therapies remain scarce.

Study objective

European registry of children and patients with congenital heart disease that
undergo ICD or CRT implantation. This will lead to a larger amount of data
leading to increased knowledge about long-term consequences and potential
complications.

Study design

European registry of children and patients with congenital heart disease that
undergo ICD or CRT implantation. After first inclusion data will be updated
every year,

Study burden and risks

No extra risks

Public
Leids Universitair Medisch Centrum

Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL
Scientific
Leids Universitair Medisch Centrum

Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Children (2-11 years)
Elderly (65 years and older)

Inclusion criteria

Implantation of ICD or CRT in children or patients with congenital heart disease

Exclusion criteria

All patients that could not be categorized as children or patients with congenital heart disease

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
50
Type :
Actual

Medical products/devices used

Generic name :
Internal Cardioverter defibrillator
Registration
:
Yes - CE intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL23626.058.08