Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

• Conditions: Congenital Heart Disease; Arrhythmia

• Registration Number: NCT04202796
• Lead Sponsor: Paris Cardiovascular Research Center (Inserm U970)

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-12-15
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-18
• Study Start: 2020-01-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of targeted arrhythmia	12 months	Rate of freedom from targeted arrhythmia recurrence

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by EQ5D3L score	6 months	Quality of life change before and after catheter ablation assessed by EQ5D3L score
Recurrence of any arrhythmia	12 months	Rate of freedom from any arrhythmia recurrence at 12 months
Long-term recurrence of targeted and any arrhythmia	24 months	Rate of freedom from targeted and any arrhythmia recurrence
Complications	1 month	Complications associated with catheter ablation
Quality of life assessed by SF36 score	6 months	Quality of life change before and after catheter ablation assessed by SF36 score

Trial Locations

Locations (1)

Georges Pompidou European Hospital; 🇫🇷 Paris, France