Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Recurrence of targeted arrhythmia
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Recurrence of targeted arrhythmia
Time Frame: 12 months
Rate of freedom from targeted arrhythmia recurrence
Secondary Outcomes
- Quality of life assessed by EQ5D3L score(6 months)
- Recurrence of any arrhythmia(12 months)
- Long-term recurrence of targeted and any arrhythmia(24 months)
- Complications(1 month)
- Quality of life assessed by SF36 score(6 months)