European Pediatric Catheter Ablation Registry

NCT ID: NCT01691573

Last Updated: 2012-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrhythmias

Keywords

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ablation procedure pediatric european cardiac arrhythmias registry observational prospective catheter cryoablation atrioventricular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role lead

Responsible Party

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Paolo De Filippo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Cantù, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.

Locations

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University Hospital Motol

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Ospedali Riuniti di Bergamo

Bergamo, BG, Italy

Site Status RECRUITING

Ospedali Manzoni

Lecco, LE, Italy

Site Status NOT_YET_RECRUITING

Ospedale S. Raffaele

Milan, MI, Italy

Site Status NOT_YET_RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status NOT_YET_RECRUITING

Countries

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Czechia Germany Italy Netherlands

Central Contacts

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Francesco Cantù, MD

Role: CONTACT

Phone: 0341 489 492

Email: [email protected]

Other Identifiers

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EU01

Identifier Type: -

Identifier Source: org_study_id