Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Congenital Heart Disease Clinical Trial

— CATCH-Registry  

Official title:

Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202796
• Other study ID #: MR2C2001
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2021
• Source: Paris Cardiovascular Research Center (Inserm U970)
• Contact: Victor Waldmann, MD, MPH
• Phone: +33676098007
• Email: victor.waldmann[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Catheter ablation
Catheter ablation of arrhythmia

Locations

Country	Name	City	State
France	Georges Pompidou European Hospital	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Paris Cardiovascular Research Center (Inserm U970)	Centre Chirurgical Marie Lannelongue, Clinique Pasteur Toulouse, European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of targeted arrhythmia	Rate of freedom from targeted arrhythmia recurrence	12 months
Secondary	Recurrence of any arrhythmia	Rate of freedom from any arrhythmia recurrence at 12 months	12 months
Secondary	Long-term recurrence of targeted and any arrhythmia	Rate of freedom from targeted and any arrhythmia recurrence	24 months
Secondary	Complications	Complications associated with catheter ablation	1 month
Secondary	Quality of life assessed by SF36 score	Quality of life change before and after catheter ablation assessed by SF36 score	6 months
Secondary	Quality of life assessed by EQ5D3L score	Quality of life change before and after catheter ablation assessed by EQ5D3L score	6 months