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European Pediatric Catheter Ablation Registry (EUROPA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Paolo De Filippo, Ospedali Riuniti di Bergamo.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Paolo De Filippo, Ospedali Riuniti di Bergamo Identifier:
First received: September 11, 2012
Last updated: September 24, 2012
Last verified: September 2012
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.

Cardiac Arrhythmias

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Pediatric Catheter Ablation Registry

Further study details as provided by Paolo De Filippo, Ospedali Riuniti di Bergamo:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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)

Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
European pediatric population

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01691573

Contact: Francesco Cantù, MD 0341 489 492

Czech Republic
University Hospital Motol Not yet recruiting
Prague, Czech Republic, 150 00
Principal Investigator: Jan Janousek, MD         
Herzzentrum Leipzig GmbH Not yet recruiting
Leipzig, Germany, 04289
Principal Investigator: Roman Gebauer, MD         
Ospedali Riuniti di Bergamo Recruiting
Bergamo, BG, Italy, 24128
Principal Investigator: Paolo De Filippo, MD         
Ospedali Manzoni Not yet recruiting
Lecco, LE, Italy, 23900
Principal Investigator: Francesco Cantu, MD         
Ospedale S. Raffaele Not yet recruiting
Milano, MI, Italy, 20132
Principal Investigator: Paolo Della Bella, MD         
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands, 2300
Principal Investigator: Nico Blom, MD         
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Principal Investigator: Francesco Cantù, MD Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
  More Information

Responsible Party: Paolo De Filippo, Principal Investigator, Ospedali Riuniti di Bergamo Identifier: NCT01691573     History of Changes
Other Study ID Numbers: EU01
Study First Received: September 11, 2012
Last Updated: September 24, 2012

Keywords provided by Paolo De Filippo, Ospedali Riuniti di Bergamo:

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 19, 2017