NCT01691573

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 25, 2012

Status Verified

September 1, 2012

Enrollment Period

4 years

First QC Date

September 11, 2012

Last Update Submit

September 24, 2012

Conditions

Cardiac Arrhythmias

Keywords

ablationprocedurepediatriceuropeancardiacarrhythmiasregistryobservationalprospectivecathetercryoablationatrioventricular

Outcome Measures

Primary Outcomes (1)

  • To collect data on ablation procedures in the European pediatric population.

    Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)

    After 12 months from the ablation procedure

Secondary Outcomes (1)

  • To describe and compare different ablation methodologies

    After 12 months from the ablation procedure

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

European pediatric population

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University Hospital Motol

Prague, 150 00, Czechia

NOT YET RECRUITING

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

NOT YET RECRUITING

Ospedali Riuniti di Bergamo

Bergamo, BG, 24128, Italy

RECRUITING

Ospedali Manzoni

Lecco, LE, 23900, Italy

NOT YET RECRUITING

Ospedale S. Raffaele

Milan, MI, 20132, Italy

NOT YET RECRUITING

Leiden University Medical Center

Leiden, 2300, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Francesco Cantù, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Cantù, MD

CONTACT

0341 489 492f.cantu@ospedale.lecco.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 24, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 25, 2012

Record last verified: 2012-09

Locations

CZ(1)IT(3)DE(1)NL(1)