European Pediatric Catheter Ablation Registry

A.O. Ospedale Papa Giovanni XXIII

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Cardiac Arrhythmias

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

University Hospital Motol

Prague, Czechia

NOT_YET_RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, Germany

NOT_YET_RECRUITING

Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: After 12 months from the ablation procedure

Secondary Outcomes

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)

Time frame: After 12 months from the ablation procedure

Central Contacts

Francesco Cantù, MD

CONTACT

0341 489 492 f.cantu@ospedale.lecco.it

Data from ClinicalTrials.gov

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