Clinical trials: Tetralogy of Fallot
Hypoplastic Left Heart Syndrome, Tetralogy of Fallot
Examining Developmental Changes in Heart Contractions of Children With Congenital Heart Defects
Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the…
- Trial name
- NCT00860327
- Where
- United States
- Volunteers
- 375 people
- Sponsor
- Emory University
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
Congenital Disorders
Optimal Timing for Repair of Right-to-Left Shunt Lesions
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects. The secondary aim being define the criteria for failing medical therapy.
- Trial name
- NCT00268099
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Children's Healthcare of Atlanta
Congenital Heart Disease, Tetralogy of Fallot
Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome
Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair.
- Conditions
- Congenital Heart Disease, Tetralogy of Fallot, Neutrophil-lymphocyte Ratio, Absolute Lymphocyte Count
- Trial name
- NCT05976204
- Testing
- ToF primary repair
- Where
- Indonesia
- Volunteers
- 501 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
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
Pulmonary Regurgitation, Tetralogy of Fallot
Multi-center Trial of Percutaneous Pulmonary Valve Implantation With Venus-p
Venus-P Valve (Venus Medtech, Shanghai, China) is the first self-expandable interventional Pulmonary Valve, which is composed of a Nitinol multilevel support frame with a tri-leaflet porcine pericardial tissue valve, and a 14-22…
- Trial name
- Venus-P (NCT02590679)
- Testing
- Venues-P Valve
- Where
- 3 sites in China
- Volunteers
- 44 people
- Sponsor
- Shanghai Zhongshan Hospital
Tetralogy of Fallot With Pulmonary Stenosis
Right and Left Ventricle Remodeling Predictors After Pulmonary Valve Replacement in Patients With Repaired Tetralogy of Fallot
Long term survival of patients with repaired tetralogy of Fallot is excellent (about 85% at 35 year-old). However these patients are exposed to residual pulmonary stenosis (PS) and/or pulmonary regurgitation (PR).
- Trial name
- NCT02186691
- Testing
- MRI
- Where
- France
- Volunteers
- 11 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Congenital Heart Disease, Aortic Root Dilatation
Predictors of Aortic Root Dilatation in Tetralogy of Fallot Patients
To predict vulnerable patients for aortic root dilatation in TOF patients using CT as a reliable imaging modality, thus aiding early intervention, and identifying those who will require strict follow-up.
- Conditions
- Congenital Heart Disease, Aortic Root Dilatation, Tetralogy of Fallot
- Trial name
- NCT06081855
- Testing
- CT
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Assiut University
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Disease, Fallot Tetralogy
Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction.
- Conditions
- Congenital Heart Disease, Fallot Tetralogy, Ventricular Arrythmia, Pulmonary Valve Regurgitation
- Trial name
- NCT04205461
- Testing
- Programmed ventricular stimulation
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Paris Cardiovascular Research Center (Inserm U970)
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 Atresia With Ventricular Septal Defect, Tetralogy of Fallot With Pulmonary Atresia
Choice of Palliative Procedures for Pulmonary Atresia With Ventricular Septal Defect Patients
The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified…
- Trial name
- NCT02861963
- Testing
- Experimental: RVOT reconstruction by femoral allogenic vein valve conduit, Systemic-to-pulmonary artery shunts
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Tetralogy of Fallot, Hypoplastic Left Heart Syndrome
Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease
Positive intra-thoracic pressures induced by mechanical ventilation can negatively impact right heart hemodynamics by restricting systemic venous return and increasing right ventricular afterload.
- Conditions
- Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital
- Trial name
- NCT04581668
- Testing
- Two ventilation periods with two different modes: conventional ventilation followed by NAVA.
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- St. Justine's Hospital
Tetralogy of Fallot With Pulmonary Stenosis, Heart Failure
Quantifying New Heart Muscle Cells
Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise…
- Trial name
- NCT06587165
- Testing
- N15-thymidine
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Weill Medical College of Cornell University
Congenital Heart Defect, Single-ventricle
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow.
- Conditions
- Congenital Heart Defect, Single-ventricle, Coarctation of Aorta, Atrioventricular Canal
- Trial name
- NCT04106479
- Testing
- NIRS evaluation
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Tetralogy of Fallot, Congenital Heart Disease
Tetralogy of Fallot for Life
The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair.
- Conditions
- Tetralogy of Fallot, Congenital Heart Disease, Congenital Heart Defect
- Trial name
- TOF-LIFE (NCT02968264)
- Where
- 20 sites in United States, Australia and 10 more
- Volunteers
- 1,108 people
- Sponsor
- Population Health Research Institute