Arrhythmia, Congenital Heart Disease
Conditions
Keywords
catheter ablation
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.
Interventions
PROCEDURECatheter ablation
Catheter ablation of arrhythmia
Sponsors
European Georges Pompidou Hospital
Centre Chirurgical Marie Lannelongue
Clinique Pasteur Toulouse
Paris Cardiovascular Research Center (Inserm U970)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of targeted arrhythmia | 12 months | Rate of freedom from targeted arrhythmia recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Quality of life assessed by EQ5D3L score | 6 months | Quality of life change before and after catheter ablation assessed by EQ5D3L score |
Countries
France
Contacts
Primary ContactVictor Waldmann, MD, MPH
Outcome results
None listed