Cyanotic Congenital Heart DiseaseNCT07866911
RVOT Stenting Versus Surgical RV-PA Conduit in Cyanotic Adults
An observational study of Cyanotic Congenital Heart Disease and Right Ventricular Outflow Tract Obstruction, run by Assiut University.
Trial summary
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cyanotic Congenital Heart Disease, Right Ventricular Outflow Tract Obstruction
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 20 Jan 2028
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients aged 16 years or older with cyanotic congenital heart disease and significant right ventricular outflow tract obstruction undergoing either percutaneous RVOT stenting or surgical RV-PA conduit placement at Aswan Heart Center.
Who may be able to join
- - Age 16 years or older
- Cyanotic congenital heart disease with significant right ventricular outflow tract obstruction requiring intervention
- Undergoing either percutaneous RVOT stenting or surgical right ventricle-to-pulmonary artery conduit placement
- Available baseline clinical, echocardiographic, and cardiac CT data
- Written informed consent
Who cannot join
- - Concomitant major cardiac surgery other than RV-PA conduit placement
- Contraindications to contrast-enhanced cardiac CT
- Inadequate CT image quality
- Incomplete clinical or imaging data
- Loss to follow-up before planned post-procedural assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Percutaneous Right Ventricular Outflow Tract Stenting Versus Surgical Right Ventricle-to-Pulmonary Artery Conduit Placement in Cyanotic Adults
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.
Read the detailed description
Cyanotic congenital heart disease in adults often involves significant right ventricular outflow tract obstruction. Establishing adequate pulmonary blood flow can be achieved by percutaneous right ventricular outflow tract (RVOT) stenting or surgical right ventricle-to-pulmonary artery (RV-PA) conduit placement.
This observational study will compare changes in systemic oxygen saturation, echocardiographic parameters, and clinical outcomes between the two treatment approaches in adult patients aged 16 years or older.
- Keywords
- Oxygen saturation, Congenital heart disease, RVOT stenting, RV-PA conduit, Cyanotic adults
- Medical subject headings
- Ventricular Outflow Obstruction, Right, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous RVOT Stenting | Adult patients undergoing percutaneous right ventricular outflow tract stent implantation. | |
| Surgical RV-PA Conduit | Adult patients undergoing surgical right ventricle-to-pulmonary artery conduit placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systemic oxygen saturation
Mean change in resting systemic oxygen saturation (SpO2) in percentage from baseline to 12 months.
Measured: At 12 months
Secondary outcomes (5)
Change in peak RVOT gradient
Mean change in peak right ventricular outflow tract gradient in mmHg measured by echocardiography.
Measured: At 12 months
Change in TAPSE
Mean change in tricuspid annular plane systolic excursion (TAPSE) in millimeters measured by echocardiography.
Measured: At 12 months
Number of patients with improvement in NYHA class
Number of patients showing improvement of at least one New York Heart Association functional class.
Measured: At 12 months
Length of hospital stay
Mean length of hospital stay in days after the index procedure.
Measured: At 1 month
Number of patients requiring reintervention
Number of patients who undergo unplanned reintervention during follow-up.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanotic Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohamed Ahmed Soliman, Assiut University
- Investigators
- Yehia T Kishk, prof, Study chair, Cardiovascular Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866911
- Sponsor's protocol ID
- RVOT-Stent-vs-Conduit-Assiut
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Right Ventricular Outflow Tract Stenting Versus Surgical Right Ventricle-to-Pulmonary Artery Conduit Placement in Cyanotic Adults
- ClinicalTrials.gov ID
- NCT07866911
- Acronym / sponsor ID
- RVOT-Stent-vs-Conduit-Assiut
- Keywords
- Oxygen saturation, Congenital heart disease, RVOT stenting, RV-PA conduit, Cyanotic adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 20 Jan 2028 (estimated)
- First posted
- 8 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.
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.
Detailed description
Cyanotic congenital heart disease in adults often involves significant right ventricular outflow tract obstruction. Establishing adequate pulmonary blood flow can be achieved by percutaneous right ventricular outflow tract (RVOT) stenting or surgical right ventricle-to-pulmonary artery (RV-PA) conduit placement.
This observational study will compare changes in systemic oxygen saturation, echocardiographic parameters, and clinical outcomes between the two treatment approaches in adult patients aged 16 years or older.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous RVOT Stenting | – | –Adult patients undergoing percutaneous right ventricular outflow tract stent implantation. |
| Surgical RV-PA Conduit | – | –Adult patients undergoing surgical right ventricle-to-pulmonary artery conduit placement. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients aged 16 years or older with cyanotic congenital heart disease and significant right ventricular outflow tract obstruction undergoing either percutaneous RVOT stenting or surgical RV-PA conduit placement at Aswan Heart Center.
Key inclusion criteria (5 listed)
- - Age 16 years or older
- Cyanotic congenital heart disease with significant right ventricular outflow tract obstruction requiring intervention
- Undergoing either percutaneous RVOT stenting or surgical right ventricle-to-pulmonary artery conduit placement
- Available baseline clinical, echocardiographic, and cardiac CT data
- Written informed consent
Key exclusion criteria (5 listed)
- - Concomitant major cardiac surgery other than RV-PA conduit placement
- Contraindications to contrast-enhanced cardiac CT
- Inadequate CT image quality
- Incomplete clinical or imaging data
- Loss to follow-up before planned post-procedural assessment
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
Change in systemic oxygen saturation
Time frame: At 12 months
Mean change in resting systemic oxygen saturation (SpO2) in percentage from baseline to 12 months.
5 secondary outcomes
Change in peak RVOT gradient
Time frame: At 12 months
Change in TAPSE
Time frame: At 12 months
Number of patients with improvement in NYHA class
Time frame: At 12 months
Length of hospital stay
Time frame: At 1 month
Number of patients requiring reintervention
Time frame: At 12 months
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 8 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cyanotic Congenital Heart Disease
Not yet recruiting
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
Congenital Heart Disease, Open Heart Surgery
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
RecruitingObservational study
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
Congenital Heart Disease (CHD), Univentricular Heart
Active, not recruitingObservational study
A Comparison of Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases
Congenital Heart Disease
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.
Yehia T Kishk, prof study chair
Cardiovascular Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Cyanotic Congenital Heart Disease and Right Ventricular Outflow Tract Obstruction, run by Assiut University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Fatma A Soliman, Resident (+20 10 70114234, Felkomy12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic oxygen saturation (time frame: At 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 8 Oct 2026.