European Pediatric Catheter Ablation Registry (EUROPA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by A.O. Ospedale Papa Giovanni XXIII
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
  Purpose

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.


Condition
Cardiac Arrhythmias

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

Resource links provided by NLM:


Further study details as provided by A.O. Ospedale Papa Giovanni XXIII:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

European pediatric population

Criteria

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 ClinicalTrials.gov identifier: NCT01691573

Contacts
Contact: Francesco Cantù, MD 0341 489 492 f.cantu@ospedale.lecco.it

Locations
Czech Republic
University Hospital Motol Not yet recruiting
Prague, Czech Republic, 150 00
Principal Investigator: Jan Janousek, MD         
Germany
Herzzentrum Leipzig GmbH Not yet recruiting
Leipzig, Germany, 04289
Principal Investigator: Roman Gebauer, MD         
Italy
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         
Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands, 2300
Principal Investigator: Nico Blom, MD         
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Francesco Cantù, MD Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
  More Information

No publications provided

Responsible Party: Paolo De Filippo, Principal Investigator, Ospedali Riuniti di Bergamo
ClinicalTrials.gov Identifier: NCT01691573     History of Changes
Other Study ID Numbers: EU01
Study First Received: September 11, 2012
Last Updated: September 24, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by A.O. Ospedale Papa Giovanni XXIII:
ablation
procedure
pediatric
european
cardiac
arrhythmias
registry
observational
prospective
catheter
cryoablation
atrioventricular

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014