Congenital Heart DiseaseNCT04205461
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
An observational study of Congenital Heart Disease and Fallot Tetralogy, run by Paris Cardiovascular Research Center (Inserm U970) at 1 site in France.
Trial summary
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia
- What is being tested?
- Programmed ventricular stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement
Who may be able to join
- All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement
Who cannot join
- Absence of patient's consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Paris Cardiovascular Research Center
Paris, 75015
Victor Waldmann, MD, MPH, +33676098007, victor.waldmann@gmail.com
Wided Msakni, MS, +33156093656, wided.msakni@aphp.fr
About this study
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.
Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.
Read more
While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.
At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.
The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.
- Conditions
- Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia, Pulmonary Valve Regurgitation
- Being tested
- Programmed ventricular stimulation
- Keywords
- programmed ventricular stimulation, catheter ablation, electrophysiology study, tetralogy of Fallot, pulmonary valve replacement
- Medical subject headings
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Programmed ventricular stimulationProcedure or surgery
Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.
| Study group | Role | What they receive |
|---|---|---|
| Programmed ventricular stimulation before PVR | Not described Receives: Procedure: Programmed ventricular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation
Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained > 30 secondes during programmed ventricular stimulation
Measured: During ventricular programmed stimulation
Secondary outcomes (3)
Critical isthmus involved in ventricular tachycardias induced
Description of different critical isthmus involved in ventricular tachycardias induced. Electrophysiological characteristics will be analyzed (conduction velocity, voltage, fragmentation, lenght, width).
Measured: During ventricular programmed stimulation
Complications associated with programmed ventricular stimulation
Complications considered:
- death
- vascular complications
- pericardial effusion
- stroke
- atrioventricular block
- heart failure
Measured: 1 month
Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement
Sustained ventricular tachycardias or ventricular fibrillations > 30 secondes and sudden cardiac deaths will be considered
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (estimated)
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, Hopital Louis Pradel, Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
- Investigators
- Victor Waldmann, MD, MPH, Principal investigator, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205461
- Sponsor's protocol ID
- ParisCardioRC
- 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
- Undecided
Publications
Waldmann V, Bessiere F, Gardey K, Bakloul M, Belli E, Bonnet D, Chaussade AS, Cohen S, Delasnerie H, Dib N, Di Filippo S, Dulac A, Hascoet S, Henaine R, Iserin L, Karsenty C, Ladouceur M, Legendre A, Malekzadeh-Milani S, Mostefa Kara M, Radojevic J, Ratsimandresy M, Marijon E, Maltret A, Khairy P, Combes N. Systematic Electrophysiological Study Prior to Pulmonary Valve Replacement in Tetralogy of Fallot: A Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011745. doi: 10.1161/CIRCEP.122.011745. Epub 2023 May 12.
PubMed 37170812
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
- Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT04205461
- Acronym / sponsor ID
- ParisCardioRC
- Conditions
- Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia, Pulmonary Valve Regurgitation
- Keywords
- programmed ventricular stimulation, catheter ablation, electrophysiology study, tetralogy of Fallot, pulmonary valve replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Paris Cardiovascular Research Center (Inserm U970)Other government
- Collaborators
- European Georges Pompidou Hospital, Centre Chirurgical Marie Lannelongue, Clinique Pasteur Toulouse, Hopital Louis Pradel, Hôpital Necker-Enfants Malades
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 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.
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.
Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.
While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.
At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.
The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Programmed ventricular stimulation before PVR | – | Procedure: Programmed ventricular stimulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement
Key inclusion criteria (1 listed)
- All patients with repaired tetralogy of Fallot referred for surgical or percutaneous pulmonary valve replacement
Key exclusion criteria (1 listed)
- Absence of patient's consent
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 |
|---|---|---|
| Programmed ventricular stimulationProgrammed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients. | Procedure or surgery | Programmed ventricular stimulation before PVR |
Primary outcome
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation
Time frame: During ventricular programmed stimulation
Rate of sustained monomorphic or polymorphic ventricular tachycardia or ventricular fibrillation sustained > 30 secondes during programmed ventricular stimulation
3 secondary outcomes
Critical isthmus involved in ventricular tachycardias induced
Time frame: During ventricular programmed stimulation
Complications associated with programmed ventricular stimulation
Time frame: 1 month
Rate of ventricular arrhythmias during the follow-up after pulmonary valve replacement
Time frame: 24 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.
- Derived from this study: PubMed 37170812Waldmann V, Bessiere F, Gardey K, Bakloul M, Belli E, Bonnet D, Chaussade AS, Cohen S, Delasnerie H, Dib N, Di Filippo S, Dulac A, Hascoet S, Henaine R, Iserin L, Karsenty C, Ladouceur M, Legendre A, Malekzadeh-Milani S, Mostefa Kara M, Radojevic J, Ratsimandresy M, Marijon E, Maltret A, Khairy P, Combes N. Systematic Electrophysiological Study Prior to Pulmonary Valve Replacement in Tetralogy of Fallot: A Prospective Multicenter Study. Circ Arrhythm Electrophysiol. 2023 Jun;16(6):e011745. doi: 10.1161/CIRCEP.122.011745. Epub 2023 May 12.
- Individual participant dataSharing planned: Undecided
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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
European Georges Pompidou Hospital
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 Fallot Tetralogy, 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 1 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?
Positive programmed ventricular stimulation defined as inducibility of sustained ventricular tachycardia or fibrillation (time frame: During ventricular programmed stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04205461, which also lists 1 linked publication.
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.