European Pediatric Catheter Ablation Registry

Cardiac Arrhythmias Clinical Trial

— EUROPA  

Official title:

European Pediatric Catheter Ablation Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01691573
• Other study ID #: EU01
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2012
• Last updated: September 24, 2012
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: September 2012
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Francesco Cantù, MD
• Phone: 0341 489 492
• Email: f.cantu[@]ospedale.lecco.it
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Observational

Clinical Trial Summary

The main objective of the European Pediatric Catheter Ablation Registry is to collect data on ablation procedures in the European pediatric population in order to improve the management of this subset of patients.

Description:

Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and has become first-line therapy for managing many pediatric patients with atrioventricular accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia.

Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps still have to be filled. On a European perspective, lack of a dedicated scientific society has limited so far the collection and sharing of data among the most experienced centers.

Actually there are no sufficient data available about the management of pediatric patients undergoing ablation in clinical practice, in particular regarding indications, methodology and clinical follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric patients scheduled to any kind of an ablation procedure;

• Patient´s age between 0 and 18 years;

• Legal guardians understand the nature of the procedure, are willing to comply with study follow-up evaluations, and provide written informed consent prior to the procedure.

Exclusion Criteria:

• Patient unable to comply with follow-up schedule;

• Patient has medical conditions that preclude protocol compliance or limit study participation;

• Legal guardian or patient unwilling or unable to provide informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmias

Locations

Country	Name	City	State
Czech Republic	University Hospital Motol	Prague
Germany	Herzzentrum Leipzig GmbH	Leipzig
Italy	Ospedali Riuniti di Bergamo	Bergamo	BG
Italy	Ospedali Manzoni	Lecco	LE
Italy	Ospedale S. Raffaele	Milano	MI
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Countries where clinical trial is conducted

Czech Republic,  Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect data on ablation procedures in the European pediatric population.	Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)	After 12 months from the ablation procedure	Yes
Secondary	To describe and compare different ablation methodologies	Rate of index arrhythmia recurrence and rate of complications will be compared for different ablation technology (electroanatomical mapping system vs standard mapping) and for different energy source(radiofrequency vs cryo)	After 12 months from the ablation procedure	No