European Pediatric Catheter Ablation Registry

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT01691573
• Lead Sponsor: A.O. Ospedale Papa Giovanni XXIII

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-24
• Last Update Submitted: 2012-09-24
• Last Update Posted: 2012-09-25
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To collect data on ablation procedures in the European pediatric population.	After 12 months from the ablation procedure	Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)

Secondary Outcome Measures

Name	Time	Method
To describe and compare different ablation methodologies	After 12 months from the ablation procedure	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)

Trial Locations

Locations (6)

University Hospital Motol; 🇨🇿 Prague, Czech Republic

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Ospedali Manzoni; 🇮🇹 Lecco, LE, Italy

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, BG, Italy

Ospedale S. Raffaele; 🇮🇹 Milano, MI, Italy