Congenital Heart DiseaseCATCH-RegistryNCT04202796
Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
An observational study of Congenital Heart Disease and Arrhythmia, run by Paris Cardiovascular Research Center (Inserm U970) at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Arrhythmia
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with congenital heart disease referred for catheter ablation
Who may be able to join
- All patients with congenital heart disease referred for catheter ablation
Who cannot join
- Absence of patient's consent
- Patient under guardianship or curatorship
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Georges Pompidou European Hospital
Paris
Victor Waldmann, MD, MPH
About this study
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.
Read more
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
- Being tested
- Catheter ablation
- Keywords
- catheter ablation
- Medical subject headings
- Heart Defects, Congenital, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Catheter ablation of arrhythmia
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of targeted arrhythmia
Rate of freedom from targeted arrhythmia recurrence
Measured: 12 months
Secondary outcomes (5)
Recurrence of any arrhythmia
Rate of freedom from any arrhythmia recurrence at 12 months
Measured: 12 months
Long-term recurrence of targeted and any arrhythmia
Rate of freedom from targeted and any arrhythmia recurrence
Measured: 24 months
Complications
Complications associated with catheter ablation
Measured: 1 month
Quality of life assessed by SF36 score
Quality of life change before and after catheter ablation assessed by SF36 score
Measured: 6 months
Quality of life assessed by EQ5D3L score
Quality of life change before and after catheter ablation assessed by EQ5D3L score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Paris Cardiovascular Research Center (Inserm U970)
- Sponsor type
- Other government
- Collaborators
- European Georges Pompidou Hospital, Centre Chirurgical Marie Lannelongue, Clinique Pasteur Toulouse
- Responsible party
- Sponsor
- Investigators
- Victor Waldmann, MD, MPH, Principal investigator, Paris Cardiovascular Research Center (Inserm U970)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202796
- Sponsor's protocol ID
- MR2C2001
- Acronym
- CATCH-Registry
- Status last verified
- Mar 2021
- First submitted
- 15 Dec 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
- ClinicalTrials.gov ID
- NCT04202796
- Acronym / sponsor ID
- CATCH-Registry / MR2C2001
- Conditions
- Congenital Heart Disease, Arrhythmia
- Keywords
- catheter ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Paris Cardiovascular Research Center (Inserm U970)Other government
- Collaborators
- European Georges Pompidou Hospital, Centre Chirurgical Marie Lannelongue, Clinique Pasteur Toulouse
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with congenital heart disease referred for catheter ablation
Key inclusion criteria (1 listed)
- All patients with congenital heart disease referred for catheter ablation
Key exclusion criteria (3 listed)
- Absence of patient's consent
- Patient under guardianship or curatorship
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationCatheter ablation of arrhythmia | Procedure or surgery | – |
Primary outcome
Recurrence of targeted arrhythmia
Time frame: 12 months
Rate of freedom from targeted arrhythmia recurrence
5 secondary outcomes
Recurrence of any arrhythmia
Time frame: 12 months
Long-term recurrence of targeted and any arrhythmia
Time frame: 24 months
Complications
Time frame: 1 month
Quality of life assessed by SF36 score
Time frame: 6 months
Quality of life assessed by EQ5D3L score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Waldmann, MD, MPH principal investigator
Paris Cardiovascular Research Center (Inserm U970)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Arrhythmia, run by Paris Cardiovascular Research Center (Inserm U970) at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Waldmann, MD, MPH (+33676098007, victor.waldmann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of targeted arrhythmia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.