Clinical trials: Tetralogy of Fallot
Tetralogy of Fallot, Double Outlet Right Ventricle
Beta-blocker Administration for Cardiomyocyte Division
Heart failure is a common long-term complication in patients with congenital heart disease (CHD). Medical treatments to promote regeneration of new healthy heart muscle cells have the potential to provide new heart failure…
- Trial name
- NCT04713657
- Testing
- N-thymidine, Urine Collection, Echocardiogram
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Weill Medical College of Cornell University
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
Tetralogy of Fallot (TOF), Pulmonary Stenosis
Investigation of Tetralogy of Fallot in Neonates
Child health serves as the foundation for overall public health, with neonatal mortality recognized globally as a comprehensive indicator of national health standards and societal advancement.
- Conditions
- Tetralogy of Fallot (TOF), Pulmonary Stenosis, Ventricular Septal Defects (VSD), Double Outlet Right Ventricle
- Trial name
- RIFAN (NCT06822400)
- Testing
- corrective surgery within 28 days of birth, corrective surgery between 3-6 months of age
- Where
- 5 sites in China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
Tetralogy of Fallot (TOF), Congenital Heart Defects
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot is the most common cyanotic congenital heart disease. Management strategies vary between primary repair and staged approaches including palliative surgery.
- Trial name
- SEPT-TOF (NCT07864129)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- University Hospital, Strasbourg, France
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
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
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
Heart Disease
PULSTA TPV Observational Study
The purpose of the study is to determine the long-term follow-up clinical outcomes, effectiveness, and safety data of the PULSTA Transcatheter Pulmonary Valve (TPV) implantation in a real-world situation
- Trial name
- NCT07747207
- Where
- 9 sites in Germany, Italy and 4 more
- Volunteers
- 200 people
- Sponsor
- Taewoong Medical Co., Ltd.
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
Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes
Echo, ECG and Holter Findings After Fallot Repair in Children
Aim of my study is to detect echocardiographic, ECG and Holter changes in children who have undergone surgical repair of Tetralogy of Fallot.
- Trial name
- NCT07704346
- Testing
- echocardiography , 12-lead ECG and Holter ECG
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Sohag University
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
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
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 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, Tetralogy of Fallot
Molecular and Cellular Characterization of Cardiac Tissue in Postnatal Development
The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives.
- Trial name
- NCT00243776
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Emory University
Tetralogy of Fallot, Pulmonary Insufficiency
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to…
- Trial name
- NCT05186415
- Testing
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nemours Children's Clinic
Heart Diseases, Pulmonary Valve Regurgitation
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study
The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require…
- Conditions
- Heart Diseases, Pulmonary Valve Regurgitation, Pulmonary Valve Stenosis, Tetralogy of Fallot
- Trial name
- NCT03983512
- Testing
- PULSTA TPV System
- Where
- 11 sites in Germany, Italy and 4 more
- Volunteers
- 58 people
- Sponsor
- Taewoong Medical Co., Ltd.
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Disease, Truncus Arteriosus
High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit
The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new…
- Conditions
- Congenital Heart Disease, Truncus Arteriosus, Pulmonary Atresia, Tetralogy of Fallot
- Trial name
- Right HIIT (NCT06771687)
- Testing
- High intensity interval training
- Where
- 2 sites in Netherlands
- Volunteers
- 38 people
- Sponsor
- Erasmus Medical Center
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