Tetralogy of Fallot (TOF)SEPT-TOFNCT07864129
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
An observational study of Tetralogy of Fallot (TOF) and Congenital Heart Defects, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery. The development of pulmonary arteries is a key determinant in surgical decision-making. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Tetralogy of Fallot (TOF), Congenital Heart Defects
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2026to 18 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with Tetralogy of Fallot or related conditions managed surgically in tertiary care centers in Strasbourg and Bordeaux.
Who may be able to join
- Patients aged from birth to less than 18 years
- Patients operated at Strasbourg or Bordeaux University Hospitals between 01/01/2010 and 31/12/2024
- Patient (or legal guardians) not opposing the reuse of medical data for research purposes
Who cannot join
- Patient expressing opposition to participation in the study
- Parents/legal guardians or minor opposing data reuse
- Specific clinical forms (VDDI)
- Absence of subvalvular obstruction and absence of muscular resection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Laurent Bonnemains, MD, PhD, 33 3 88 12 74 99, laurent.bonnemains@chru-strasbourg.fr
About this study
Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery. The development of pulmonary arteries is a key determinant in surgical decision-making.
This multicenter retrospective observational study aims to evaluate the evolution of pulmonary artery dimensions using the Nakata index at key stages of patient management (birth, palliative surgery, and complete repair). The goal is to assess its predictive value in optimizing surgical strategy and improving outcomes in patients with Tetralogy of Fallot or pulmonary atresia with ventricular septal defect.
- Keywords
- Tetralogy of Fallot, Pulmonary arteries, Nakata index, Congenital heart disease, Pediatric cardiology
- Medical subject headings
- Tetralogy of Fallot, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Nakata index evolution and predictive value
Assessment of the Nakata index based on pulmonary artery diameters measured on imaging at different time points (birth, palliative surgery, complete repair), and evaluation of its association with surgical outcomes using predefined thresholds (108 and 160 mm²/m²).
Measured: From birth to complete surgical repair (retrospective data 2010-2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start18 Jun 2026
- Primary completion18 Apr 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetralogy of Fallot (TOF)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864129
- Sponsor's protocol ID
- RC26_0220
- Acronym
- SEPT-TOF
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
- ClinicalTrials.gov ID
- NCT07864129
- Acronym / sponsor ID
- SEPT-TOF / RC26_0220
- Keywords
- Tetralogy of Fallot, Pulmonary arteries, Nakata index, Congenital heart disease, Pediatric cardiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 18 Apr 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery. The development of pulmonary arteries is a key determinant in surgical decision-making.
This multicenter retrospective observational study aims to evaluate the evolution of pulmonary artery dimensions using the Nakata index at key stages of patient management (birth, palliative surgery, and complete repair). The goal is to assess its predictive value in optimizing surgical strategy and improving outcomes in patients with Tetralogy of Fallot or pulmonary atresia with ventricular septal defect.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with Tetralogy of Fallot or related conditions managed surgically in tertiary care centers in Strasbourg and Bordeaux.
Key inclusion criteria (3 listed)
- Patients aged from birth to less than 18 years
- Patients operated at Strasbourg or Bordeaux University Hospitals between 01/01/2010 and 31/12/2024
- Patient (or legal guardians) not opposing the reuse of medical data for research purposes
Key exclusion criteria (4 listed)
- Patient expressing opposition to participation in the study
- Parents/legal guardians or minor opposing data reuse
- Specific clinical forms (VDDI)
- Absence of subvalvular obstruction and absence of muscular resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nakata index evolution and predictive value
Time frame: From birth to complete surgical repair (retrospective data 2010-2024)
Assessment of the Nakata index based on pulmonary artery diameters measured on imaging at different time points (birth, palliative surgery, complete repair), and evaluation of its association with surgical outcomes using predefined thresholds (108 and 160 mm²/m²).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Related trials for Tetralogy of Fallot (TOF)
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
Active, not recruitingObservational study
ALTERRA Post-Approval Study
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
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.
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 Tetralogy of Fallot (TOF) and Congenital Heart Defects, run by University Hospital, Strasbourg, France 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Bonnemains, MD, PhD (33 3 88 12 74 99, laurent.bonnemains@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nakata index evolution and predictive value (time frame: From birth to complete surgical repair (retrospective data 2010-2024)). 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 7 Oct 2026.