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

March 8, 2021 updated by: Paris Cardiovascular Research Center (Inserm U970)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Georges Pompidou European hospital
        • Contact:
          • Victor Waldmann, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with congenital heart disease referred for catheter ablation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of targeted arrhythmia
Time Frame: 12 months
Rate of freedom from targeted arrhythmia recurrence
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paris Cardiovascular Research Center (Inserm U970)

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

December 15, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR2C2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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