European Pediatric Catheter Ablation Registry (EUROPA)

September 24, 2012 updated by: Paolo De Filippo, A.O. Ospedale Papa Giovanni XXIII
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Prague, Czech Republic, 150 00
        • Not yet recruiting
        • University Hospital Motol
        • Principal Investigator:
          • Jan Janousek, MD
      • Leipzig, Germany, 04289
        • Not yet recruiting
        • Herzzentrum Leipzig GmbH
        • Principal Investigator:
          • Roman Gebauer, MD
    • BG
      • Bergamo, BG, Italy, 24128
        • Recruiting
        • Ospedali Riuniti di Bergamo
        • Principal Investigator:
          • Paolo De Filippo, MD
    • LE
      • Lecco, LE, Italy, 23900
        • Not yet recruiting
        • Ospedali Manzoni
        • Principal Investigator:
          • Francesco Cantu, MD
    • MI
      • Milano, MI, Italy, 20132
        • Not yet recruiting
        • Ospedale S. Raffaele
        • Principal Investigator:
          • Paolo Della Bella, MD
      • Leiden, Netherlands, 2300
        • Not yet recruiting
        • Leiden University Medical Center
        • Principal Investigator:
          • Nico Blom, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

European pediatric population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe and compare different ablation methodologies
Time Frame: 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)
After 12 months from the ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francesco Cantù, MD, Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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