Text Size

European Pediatric Catheter Ablation Registry (EUROPA)

This study is currently recruiting participants.
Verified September 2012 by Ospedali Riuniti di Bergamo
Sponsor:
Information provided by (Responsible Party):
Paolo De Filippo, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier:
NCT01691573
First received: September 11, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes

September 11, 2012
September 24, 2012
July 2012
July 2016   (final data collection date for primary outcome measure)
To collect data on ablation procedures in the European pediatric population. [ Time Frame: After 12 months from the ablation procedure ] [ Designated as safety issue: Yes ]
Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)
Same as current
Complete list of historical versions of study NCT01691573 on ClinicalTrials.gov Archive Site
To describe and compare different ablation methodologies [ Time Frame: After 12 months from the ablation procedure ] [ Designated as safety issue: No ]
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)
To describe and compare different ablation methodologies [ Time Frame: After 12 months from the ablation procedure ] [ Designated as safety issue: No ]
We seek to evaluate if rate of primary outcome differs by ablation methodology and/or energy source
Not Provided
Not Provided
 
European Pediatric Catheter Ablation Registry
European Pediatric Catheter Ablation Registry

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

European pediatric population
Cardiac Arrhythmias
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
July 2016
July 2016   (final data collection date for primary outcome measure)

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.
Both
up to 18 Years
No
Contact: Francesco Cantù, MD 0341 489 492 f.cantu@ospedale.lecco.it
Czech Republic,   Germany,   Italy,   Netherlands
 
NCT01691573
EU01
No
Paolo De Filippo, Ospedali Riuniti di Bergamo
Ospedali Riuniti di Bergamo
Not Provided
Principal Investigator: Francesco Cantù, MD Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
Ospedali Riuniti di Bergamo
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP