Clinical trials: Tetrology of Fallot
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, 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
Myocardial Protection in TOF Repair
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique
Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.
- Trial name
- TOF (NCT02646254)
- Testing
- blood cardioplegia, del nido cardioplegia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- SUNDER LAL NEGI
Congenital Heart Disease in Children, Cardiopulmonary Bypass
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD.
- Conditions
- Congenital Heart Disease in Children, Cardiopulmonary Bypass, Tetralogy of Fallot
- Trial name
- NCT05579964
- Testing
- Dexmedetomidine Hcl 100 Mcg/mL Inj
- Where
- Indonesia
- Volunteers
- 66 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Tetralogy of Fallot, Congenital Heart Defects
Exercise Training Strategies for Children With Repaired Tetralogy of Fallot
The investigators will explore the feasibility and safety of two exercise interventions delivered both in the hospital and in participants' homes.
- Conditions
- Tetralogy of Fallot, Congenital Heart Defects, Congenital Abnormalities, Cardiovascular Diseases
- Trial name
- NCT04208893
- Testing
- Exercise training
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- The Hospital for Sick Children
ARDS, TTM
TwichView-guided Atricurium Dose Adjustment Trial
The goal of this clinical trial is to learn if using a monitor that measures muscle response can lower the amount of muscle relaxant medicine needed in adults who are treated in an intensive care unit (ICU) and need a continuous…
- Conditions
- ARDS, TTM, ECMO, Neuromuscular Blockade Monitoring
- Trial name
- NCT07807046
- Testing
- EMG-based quantitative TOF-guided atracurium titration
- Where
- Taiwan
- Volunteers
- 120 people
- Sponsor
- Fu Jen Catholic University Hospital
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
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 Disorders
MRI Assessment of RV Function: Patients With TOF or Aortic Coarctation
At Children's Healthcare of Atlanta at Egleston, it is standard of care to do a cardiac MRI on patients with the diagnosis of Tetralogy of Fallot and Aortic Coarctation to evaluate heart function.
- Trial name
- NCT00277901
- Where
- United States
- Volunteers
- 390 people
- Sponsor
- Children's Healthcare of Atlanta
Tetralogy of Fallot
Comparison of RVOT Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing TOF Repair
The primary objective of the study will be to compare intraoperative post TOF repair RVOT gradient under two different anaesthetic depths.
- Trial name
- NCT03234582
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Transposition of the Great Arteries, Tetralogy of Fallot
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery…
- Conditions
- Transposition of the Great Arteries, Tetralogy of Fallot, Ventricular Septal Defect
- Trial name
- NCT01915277
- Testing
- Dexmedetomidine
- Where
- 4 sites in United States
- Volunteers
- 119 people
- Sponsor
- Carelon Research
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
Analysis of RV-Dysfunction in Fallot Patients
In the presented study TDI will be used as a modern technique to characterize RV-function in Fallot patients at rest and during different exercise conditions.
- Trial name
- Fallot (NCT03835494)
- Testing
- Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Tetralogy of Fallot, Heart Defects, Congenital
Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System
Rationale: The prevalence of adult patients with congenital heart disease (CHD) has steadily increased over the last decades, due to the advances in cardiac surgery.
- Conditions
- Tetralogy of Fallot, Heart Defects, Congenital, Ventricular Dysfunction, Right
- Trial name
- Redefine (NCT02010905)
- Testing
- Losartan
- Where
- 6 sites in Netherlands
- Volunteers
- 120 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
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, Implantable Defibrillator User
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.
- Conditions
- Tetralogy of Fallot, Implantable Defibrillator User, Congenital Heart Disease, Sudden Cardiac Death
- Trial name
- DAI-T4F (NCT03837574)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Paris Sudden Death Expertise Center
Congenital Heart Disease, Congenital Heart Defect
Myocardial FIbrosis in Repaired Tetralogy of FAllot- FIFA Study)
This study aims to study the correlation between biomarkers of myocardial fibrosis (extracellular volume fraction calculated by cardiac magnetic resonance imaging (MRI) (T1-mapping) and levels of molecular biomarkers of fibrosis)…
- Conditions
- Congenital Heart Disease, Congenital Heart Defect, Fallot Tetralogy
- Trial name
- FIFA (NCT04737135)
- Testing
- Non intervention
- Where
- 7 sites in Spain
- Volunteers
- 224 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Congenital Heart Disease
Retrospective Pulmonary Valve Replacement Imaging
This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement.
- Trial name
- NCT00446108
- Where
- 2 sites in United States
- Volunteers
- 153 people
- Sponsor
- Emory University
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