Clinical trials: Tetralogy of Fallot
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Pulmonary Stenosis, Pulmonary Regurgitation
Pulmonary Artery Repair With Covered Stents
The Covered Cheatham-Platinum Stent (CCPS) is being study for repair of tears that occur in the pulmonary artery during dilation (enlargement) of a conduit (passageway) connecting the right ventricle of the heart to the pulmonary…
- Conditions
- Pulmonary Stenosis, Pulmonary Regurgitation, Tetralogy of Fallot
- Trial name
- PARCS (NCT01824160)
- Testing
- Repair of RV-PA Conduit Disruption
- Where
- 38 sites in United States
- Volunteers
- 50 people
- Sponsor
- Johns Hopkins University
Congenital Heart Disease
Imaging by 4 DFlow in Patients With Tetralogy of Fallot
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.
- Trial name
- 4DFlowFallot (NCT03542968)
- Testing
- magnetic resonance imaging
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Pneumonia, Tetralogy of Fallot Correction
Bedside PEEP Selection in by Electrical Impedence Tomography During Mechanical Ventilation in Children
This prospective study evaluates the feasibility and safety of using Electrical Impedance Tomography (EIT) to guide PEEP selection in mechanically ventilated infants and toddlers under 3 years of age.
- Conditions
- Pneumonia, Tetralogy of Fallot Correction, Caustics Ingestion, Orthotopic Liver Transplantation
- Trial name
- BePeSEIT (NCT07319624)
- Testing
- Electrical Impedence Tomography
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Papa Giovanni XXIII Hospital
Tetralogy of Fallot (TOF), Adults With Repaired Tetralogy of Fallot
Effect of Exercises on Ventilatory Function in Adult With TOF
The goal of this clinical trial is to learn if combined inspiratory muscle training and aerobic exercise can improve ventilatory function in adults with repaired Tetralogy of Fallot (TOF).
- Trial name
- NCT07326228
- Testing
- aerobic exercise, respiratory muscle training
- Volunteers
- 60 people
- Sponsor
- Cairo University
Hypoplastic Left Heart, Tetralogy of Fallot
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication.
- Conditions
- Hypoplastic Left Heart, Tetralogy of Fallot, Tricuspid Atresia
- Trial name
- InfantDex (NCT00573066)
- Testing
- Dexmedetomidine
- Volunteers
- 56 people
- Sponsor
- Athena Zuppa
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Pulmonary Artery Stenosis, Tetralogy of Fallot
Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation
Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot…
- Conditions
- Pulmonary Artery Stenosis, Tetralogy of Fallot, Pulmonary Atresia
- Trial name
- NCT02586740
- Testing
- Pulmonary artery rehabilitation
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Aymen N Naguib
Myocardial Injury, Cardiac Surgery
Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery
The study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy Fallot patients undergoing corrective surgery.
- Trial name
- NCT05691764
- Testing
- Cyclosporin, remote ischemic preconditioning
- Where
- Indonesia
- Volunteers
- 40 people
- Sponsor
- Universitas Indonesia
Right Ventricular Dysfunction
Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot
Background: Residual pulmonary regurgitation following repair of tetralogy of Fallot, in particular the use of a transannular patch, has been shown to correlate with the development of right ventricular dysfunction.
- Trial name
- TOF-Cond (NCT00557934)
- Testing
- dobutamine
- Where
- Germany
- Volunteers
- 16 people
- Sponsor
- University Hospital Tuebingen
Magnetic Resonance Imaging, Tetralogy of Fallot
4D Velocity Mapping of the Heart in rTOF Patients
MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.
- Trial name
- CARDIOFLUX (NCT02980614)
- Testing
- 4D flow imaging
- Where
- France
- Volunteers
- 21 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Coarctation of the Aorta, Tetralogy of Fallot
Haemodynamics and Function of the Atria in Congenital Heart Disease by Cardiovascular Magnetic Resonance
The purpose of this study is to determine whether patients with repaired congenital heart disease show differences in size or function of their heart atria compared to normal controls and depending on the nature of their heart…
- Conditions
- Coarctation of the Aorta, Tetralogy of Fallot, Transposition of the Great Arteries
- Trial name
- NCT02161471
- Where
- Switzerland
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University Children's Hospital, Zurich
Tetrology of Fallot
Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
The pediatric cardiac surgery patient endures a tremendous number of physiologic alterations during surgery and cardiopulmonary bypass (CPB) that lasts well into the recovery period.
- Trial name
- NCT07184476
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Children's Hospital
Tetralogy of Fallot
Exercise Training in Adults With Corrected Tetralogy of Fallot
In this controlled trial, patients with tetralogy of Fallot will be randomized to either interval training, continuous training, or usual care groups.
- Trial name
- NCT02643810
- Testing
- Exercise training
- Where
- Slovenia
- Volunteers
- 27 people
- Sponsor
- University Medical Centre Ljubljana
Tetralogy of Fallot
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary…
- Trial name
- TOFandPVR (NCT03634072)
- Testing
- PVR
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
Tetralogy of Fallot
Early Revalvulation After Fallot Repair Improves Clinical Outcome
Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation.
- Trial name
- NCT02534792
- Testing
- Revalvulation
- Where
- Belgium
- Volunteers
- 320 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Tetralogy of Fallot (TOF), Hypoplastic Left Heart Syndrome (HLHS)
3D Modalities for Medical Student Education of Congenital Heart Disease
The goal of this clinical trial is to learn if 3D-printed heart models and augmented reality can be useful modalities to teach medical students about congenital heart disease. The main questions it aims to answer are: 1.
- Trial name
- NCT07295730
- Testing
- 3D-printed heart models and augmented reality
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Case Western Reserve University
Tetrology of Fallot, Heart Ventricle
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery.
- Conditions
- Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart
- Trial name
- Dex (NCT00576381)
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Athena Zuppa
Fallot Tetralogy
Computed Tomographic Assessment of Cardiac and Extra Cardiac Vascular Anomalies Associated With Tetralogy of Fallot
Evaluation of cardiac and extra cardiac vascular defects associated with Tetralogy of fallot in pediatric patients, regarding frequency and types of anomalies with assesment of multidetector computed tomography diagnostic value.
- Trial name
- NCT05291858
- Volunteers
- 25 people
- Sponsor
- Assiut University
Congenital Disorders
Predictors for Pulmonary Valve Replacement - Anatomic and Hemodynamic Using MRI
Magnetic Resonance Imaging (MRI) is a non-invasive test that can look at the heart without using radiation. An MRI will allow the doctors to look at the heart in order to assess how well the ventricle is pumping, the amount of…
- Trial name
- NCT00489788
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Emory University