Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

NCT04202796 | Unknown DMC

• 1 other identifier: MR2C2001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Arrhythmia

Keywords

catheter ablation

Outcome Measures

Primary Outcomes (1)

• Recurrence of targeted arrhythmia

  Rate of freedom from targeted arrhythmia recurrence

  12 months

Secondary Outcomes (5)

• 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

• Quality of life assessed by EQ5D3L score

  6 months

Interventions

Catheter ablation PROCEDURE

Catheter ablation of arrhythmia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with congenital heart disease referred for catheter ablation

You may qualify if:

• All patients with congenital heart disease referred for catheter ablation

You may not qualify if:

• Absence of patient's consent
• Patient under guardianship or curatorship
• Pregnant woman

Sponsors & Collaborators

• Paris Cardiovascular Research Center (Inserm U970): lead
• European Georges Pompidou Hospital: collaborator
• Centre Chirurgical Marie Lannelongue: collaborator
• Clinique Pasteur Toulouse: collaborator

Study Sites (1)

Georges Pompidou European Hospital

Paris, France

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Arrhythmias, Cardiac

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Victor Waldmann, MD, MPH

  Paris Cardiovascular Research Center (Inserm U970)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Waldmann, MD, MPH

CONTACT

+33676098007; victor.waldmann@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 18, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)