Skip to main content
Clinical Trials/NCT04202796
NCT04202796
Unknown
Not Applicable

Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Paris Cardiovascular Research Center (Inserm U970)1 site in 1 country300 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Paris Cardiovascular Research Center (Inserm U970)
Enrollment
300
Locations
1
Primary Endpoint
Recurrence of targeted arrhythmia
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Paris Cardiovascular Research Center (Inserm U970)
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

Loading locations...

Similar Trials