Clinical trials: Tetralogy of Fallot
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
Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
- Conditions
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect
- Trial name
- T-NOX (NCT04452188)
- Testing
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
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
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
Tetralogy of Fallot, Congenital Heart Disease
Repaired Tetralogy of Fallot: Risc Score From MRI & Clinical Data to Predict the Need for Change of Treatment
Patient with Tetralogy of Fallot need live-long surveillance after initial operative correction (rTOF). MRI is an established and important component of the standardized follow-up in this patient population.
- Trial name
- rTOF-MR-SHARP (NCT05916976)
- Testing
- cardiac MRI
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- University Medical Center Goettingen
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
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
Cardiovascular Diseases, Heart Diseases
Reproduction and Survival After Cardiac Defect Repair
To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Aortic Valve Stenosis
- Trial name
- NCT00005190
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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
Tetralogy of Fallot
Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot
Summary: The investigators aim to identify markers of right ventricular dysfunction in patients with severe pulmonary regurgitation following repair of Tetralogy of Fallot, that allow prediction of the optimal timing of the…
- Trial name
- NCT00564993
- Testing
- Dobutamin
- Where
- 11 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Competence Network for Congenital Heart Defects
Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD)
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively.
- Conditions
- Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD)
- Trial name
- NCT00848393
- Testing
- Fentanyl (High Dose), Fentanyl (Low Dose), Fentanyl (Low Dose) + Dexmedetomidine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Nationwide Children's Hospital
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
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
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.
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
Tetralogy of Fallot
Early Re-intervention in Infants and Small Children After Correction of Tetralogy of Fallot
Tetralogy of Fallot is one of the most frequent congenital heart malformations. In many cases re-interventions, surgical or catheter-based, are necessary after the repair of tetralogy of Fallot in infancy.
- Trial name
- NCT00536432
- Where
- 14 sites in Germany
- Volunteers
- 93 people
- Sponsor
- Competence Network for Congenital Heart Defects
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
Transposition of Great Vessels, Tetralogy of Fallot
Effects Branch PA Stenting d-TGA, ToF and TA
The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.
- Conditions
- Transposition of Great Vessels, Tetralogy of Fallot, Truncus Arteriosus, Pulmonary Artery Stenosis Supravalvular Congenital
- Trial name
- NCT05809310
- Testing
- Percutaneous intervention (stent) for PA stenosis
- Where
- 4 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- UMC Utrecht
Tetrology of Fallot
Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of…
- Trial name
- NCT03732742
- Testing
- TOF repair with trans-annular patch VS preservation of PV
- Volunteers
- 50 people
- Sponsor
- Assiut University