Cardiac ArrhythmiasEUROPANCT01691573
European Pediatric Catheter Ablation Registry
An observational study of Cardiac Arrhythmias, run by A.O. Ospedale Papa Giovanni XXIII at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Arrhythmias
- How many people
- Not given
- Where
- 6 sitesin 4 countries
- Study dates
- Jul 2012to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: European pediatric population
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy3 sites, 3 recruiting
- Recruiting
Ospedali Riuniti di Bergamo
Bergamo, BG, 24128
Paolo De Filippo, MD
- Not yet recruiting
Ospedali Manzoni
Lecco, LE, 23900
Francesco Cantu, MD
- Not yet recruiting
Ospedale S. Raffaele
Milan, MI, 20132
Paolo Della Bella, MD
Czechia1 site, 1 recruiting
- Not yet recruiting
University Hospital Motol
Prague, 150 00
Jan Janousek, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Herzzentrum Leipzig GmbH
Leipzig, 04289
Roman Gebauer, MD
Netherlands1 site, 1 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden, 2300
Nico Blom, MD
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrhythmias
- Keywords
- ablation, procedure, pediatric, european, cardiac, arrhythmias, registry, observational, prospective, catheter, cryoablation, atrioventricular
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After 12 months from the ablation procedure
Secondary outcomes (1)
To describe and compare different ablation methodologies
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)
Measured: After 12 months from the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo De Filippo, A.O. Ospedale Papa Giovanni XXIII
- Investigators
- Francesco Cantù, MD, Principal investigator, Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691573
- Sponsor's protocol ID
- EU01
- Acronym
- EUROPA
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Pediatric Catheter Ablation Registry
- ClinicalTrials.gov ID
- NCT01691573
- Acronym / sponsor ID
- EUROPA / EU01
- Conditions
- Cardiac Arrhythmias
- Keywords
- ablation, procedure, pediatric, european, cardiac, arrhythmias, registry, observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- European pediatric population
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To collect data on ablation procedures in the European pediatric population.
Time frame: After 12 months from the ablation procedure
Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)
1 secondary outcome
To describe and compare different ablation methodologies
Time frame: After 12 months from the ablation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
Related trials for Cardiac Arrhythmias
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Cantù, MD principal investigator
Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by A.O. Ospedale Papa Giovanni XXIII at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Czechia, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Cantù, MD (0341 489 492, f.cantu@ospedale.lecco.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect data on ablation procedures in the European pediatric population. (time frame: After 12 months from the ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.