Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

NCT ID: NCT04202796

Last Updated: 2021-03-09

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

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population.

The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures.

Most of available studies are retrospective or include a limited number of patients.

The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.

Detailed Description

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Conditions

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Congenital Heart Disease Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Catheter ablation

Catheter ablation of arrhythmia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients with congenital heart disease referred for catheter ablation

Exclusion Criteria

* Absence of patient's consent
* Patient under guardianship or curatorship
* Pregnant woman
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Georges Pompidou Hospital

OTHER

Sponsor Role collaborator

Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role collaborator

Clinique Pasteur Toulouse

OTHER

Sponsor Role collaborator

Paris Cardiovascular Research Center (Inserm U970)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor Waldmann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Paris Cardiovascular Research Center (Inserm U970)

Locations

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Georges Pompidou European Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Victor Waldmann, MD, MPH

Role: CONTACT

+33676098007

Facility Contacts

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Victor Waldmann, MD, MPH

Role: primary

Other Identifiers

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MR2C2001

Identifier Type: -

Identifier Source: org_study_id

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