- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01691573
European Pediatric Catheter Ablation Registry (EUROPA)
Study Overview
Status
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
Contacts and Locations
Study Contact
- Name: Francesco Cantù, MD
- Phone Number: 0341 489 492
- Email: f.cantu@ospedale.lecco.it
Study Locations
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Prague, Czech Republic, 150 00
- Not yet recruiting
- University Hospital Motol
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Principal Investigator:
- Jan Janousek, MD
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Leipzig, Germany, 04289
- Not yet recruiting
- Herzzentrum Leipzig GmbH
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Principal Investigator:
- Roman Gebauer, MD
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BG
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Bergamo, BG, Italy, 24128
- Recruiting
- Ospedali Riuniti di Bergamo
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Principal Investigator:
- Paolo De Filippo, MD
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LE
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Lecco, LE, Italy, 23900
- Not yet recruiting
- Ospedali Manzoni
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Principal Investigator:
- Francesco Cantu, MD
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MI
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Milano, MI, Italy, 20132
- Not yet recruiting
- Ospedale S. Raffaele
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Principal Investigator:
- Paolo Della Bella, MD
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Leiden, Netherlands, 2300
- Not yet recruiting
- Leiden University Medical Center
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Principal Investigator:
- Nico Blom, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study 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
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
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Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)
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After 12 months from the ablation procedure
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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
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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)
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After 12 months from the ablation procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Francesco Cantù, MD, Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EU01
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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