Clinical trials: Tetralogy of Fallot (TOF)
Adult Congenital Heart Disease, Congenital Heart Disease
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns…
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries
- Trial name
- ACHIEVE-SGLT2i (NCT06932081)
- Testing
- SGLT2 inhibitors
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 400 people
- Sponsor
- Leiden University Medical Center
Tetralogy of Fallot
Early Right Ventricular Function After Repair Of Tetralogy Of Fallot , An Evidence Based Study.
This study aims to assessing right ventricular function early after surgical repair of tetralogy of Fallot and identifying the risk factors associated with development of RV dysfunction.
- Trial name
- NCT03470064
- Where
- 2 sites in Egypt
- Volunteers
- 100 people
- Sponsor
- Assiut University
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
Congenital Heart Disease, Tetralogy of Fallot
Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)
The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.
- Trial name
- NCT01762124
- Testing
- Native Outflow Tract TPV
- Where
- 3 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Medtronic Heart Valves
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
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
Tetralogy of Fallot
Follow up of Post-repair Tetralogy of Fallot
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain.
- Trial name
- NCT00266188
- Where
- 14 sites in Germany
- Volunteers
- 406 people
- Sponsor
- Competence Network for Congenital Heart Defects
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
Hypoparathyroidism, Tetralogy of Fallot
Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia. II.
- Conditions
- Hypoparathyroidism, Tetralogy of Fallot, Pulmonary Valve Stenosis, Conotruncal Cardiac Defects
- Trial name
- NCT00004361
- Testing
- calcium gluconate, sodium citrate
- Volunteers
- 150 people
- Sponsor
- National Center for Research Resources (NCRR)
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
Pulmonary Regurgitation After Repair of Tetralogy of Fallot
Tetralogy of Fallot Seed Grant
Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will be recruited from the UCSF adult congenital heart disease clinic.
- Trial name
- NCT00722826
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of California, San Francisco
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
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
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
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
Tetralogy of Fallot, Cardiac Death, Sudden
Repaired Tetralogy of Fallot Italian Registry
The CMR/CT WG of the Italian pediatric cardiology society set up a multi-center observational clinical database of repaired-TOF evaluated.
- Conditions
- Tetralogy of Fallot, Cardiac Death, Sudden, Cardiac Arrhythmia, Cardiac Event
- Trial name
- RETE-Fallot (NCT05288894)
- Testing
- Cardiac magnetic resonance imaging
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliero, Universitaria Ospedali Riuniti
Anesthesia
Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair
Randomized clinical trial: comparison between Histidine-tryptophan-ketoglutarate cardioplegia and cold blood cardioplegia for myocardial protection for Fallot tetralogy patients undergoing total repair This study aims to compare…
- Trial name
- NCT05176782
- Testing
- HTK cardioplegia, Cold Cadioplegia
- Where
- Egypt
- Volunteers
- 52 people
- Sponsor
- Ain Shams University
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)
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
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