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CATCH-Registry: Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

Sponsor
Paris Cardiovascular Research Center (Inserm U970) (Other)
Overall Status
Recruiting
CT.gov ID
NCT04202796
Collaborator
European Georges Pompidou Hospital (Other), Centre Chirurgical Marie Lannelongue (Other), Clinique Pasteur Toulouse (Other)
300
Enrollment
1
Location
48
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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,

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Procedure: Catheter ablation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Recurrence of targeted arrhythmia [12 months]

    Rate of freedom from targeted arrhythmia recurrence

Secondary Outcome Measures

  1. Recurrence of any arrhythmia [12 months]

    Rate of freedom from any arrhythmia recurrence at 12 months

  2. Long-term recurrence of targeted and any arrhythmia [24 months]

    Rate of freedom from targeted and any arrhythmia recurrence

  3. Complications [1 month]

    Complications associated with catheter ablation

  4. Quality of life assessed by SF36 score [6 months]

    Quality of life change before and after catheter ablation assessed by SF36 score

  5. Quality of life assessed by EQ5D3L score [6 months]

    Quality of life change before and after catheter ablation assessed by EQ5D3L score

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Georges Pompidou European Hospital Paris France

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Victor Waldmann, MD, MPH, Paris Cardiovascular Research Center (Inserm U970)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paris Cardiovascular Research Center (Inserm U970)
ClinicalTrials.gov Identifier:
NCT04202796
Other Study ID Numbers:
  • MR2C2001
First Posted:
Dec 18, 2019
Last Update Posted:
Mar 9, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paris Cardiovascular Research Center (Inserm U970)
catheter ablation
Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital

Study Results

No Results Posted as of Mar 9, 2021