European Pediatric Catheter Ablation Registry

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01691573

Acronym

EUROPA

Enrollment

Unknown

Registered

2012-09-24

Start date

2012-07-31

Completion date

2016-07-31

Last updated

2012-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmias

Keywords

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

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To collect data on ablation procedures in the European pediatric population.	After 12 months from the ablation procedure	Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)

Secondary

Measure	Time frame	Description
To describe and compare different ablation methodologies	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)

Countries

Czechia, Germany, Italy, Netherlands

Contacts

Primary ContactFrancesco Cantù, MD

f.cantu@ospedale.lecco.it0341 489 492

Outcome results