Clinical trials: Congenital Heart Defects
Congenital Heart Disease, Heart Disease
The Genetic Basis of Congenital Heart Disease in Africa
Recent advances in genomic techniques are making possible a new wave of genetic discovery in congenital heart disease (CHD). Existing data suggests that CHD occur in Sub-Saharan Africa at frequencies similar to the rest of the…
- Trial name
- NCT01952171
- Where
- United States
- Volunteers
- 1,233 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Congenital Heart Disease, Acute Kidney Injury
Effects of Anesthetic Techniques on Renal Function
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
- Trial name
- NCT04030481
- Testing
- inhalation anesthesia, Total intravenous anesthesia
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Children's Hospital of Fudan University
Congenital Heart Disease
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will…
- Trial name
- IMMPACT (NCT03891160)
- Testing
- 3D model of heart
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Columbia 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
Congenital Heart Disease
Autus Valve Pivotal Study
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT05006404
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- 12 sites in United States
- Volunteers
- 62 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Disease
Autus Valve Continued Access Study (CAS)
Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement.
- Trial name
- NCT07466745
- Testing
- Pulmonary Valve Replacement Surgery
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Edwards Lifesciences
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Heart Diseases, Heart Failure
Global Utilization And Registry Database for Improved heArt preservatioN
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System.
- Conditions
- Heart Diseases, Heart Failure, Heart Defects, Congenital
- Trial name
- GUARDIAN (NCT04141605)
- Testing
- SherpaPak Cardiac Transport System
- Where
- 22 sites in United States, Austria and 2 more
- Volunteers
- 4,000 people
- Sponsor
- Paragonix Technologies
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation
- Trial name
- ILOCO (NCT07193719)
- Testing
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Charite University, Berlin, Germany
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Lung Volume Optimization Maneuver on Cardiac Output and Lung Compliance in Ventilated Children With Congenital Heart Disease Undergoing Surgical Repair
The aim of this randomized interventional multi-center clinical trial is to determine whether a standardized lung volume optimization maneuver (LVOM), including PEEP titration, improves outcomes in children undergoing…
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Mechanical Ventilation, Peep Titration in Lung Protective Ventilation
- Trial name
- ILOCO-CHD (NCT07486167)
- Testing
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Charite University, Berlin, Germany
Congenital Heart Disease
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Background: In Fontan Associated Liver Disease (FALD), congestion of blood in the liver causes cirrhosis. This condition can cause death. Researchers want to understand what triggers this process and find new treatments for it.
- Trial name
- NCT05213598
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy
Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial…
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Trial name
- NCT07740915
- Testing
- Ultrasound-Guided Erector Spinae Plane Block, Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Congenital Heart Disease, Executive Dysfunction
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Advances in prenatal and neonatal care have improved outcomes in children with critical congenital heart disease (CCHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have…
- Conditions
- Congenital Heart Disease, Executive Dysfunction, Attention Disorder
- Trial name
- LbH (NCT06267430)
- Testing
- Kleuter Extra training program
- Where
- 3 sites in Netherlands
- Volunteers
- 103 people
- Sponsor
- Erasmus Medical Center
Congenital Heart Disease
Effect of Sacubitril-Valsartan on Cardiac Structure and Function
The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin…
- Trial name
- NCT06693674
- Testing
- Entresto Pill
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Mayo Clinic
Congenital Heart Disease, Cardiac Output
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
This pilot feasibility study will evaluate UltraTrac, an investigational noninvasive wearable device for continuous cardiac output monitoring, in patients with congenital heart disease.
- Conditions
- Congenital Heart Disease, Cardiac Output, Hemodynamic Monitoring, Pediatric Heart Disease
- Trial name
- UltraTrac (NCT07866573)
- Testing
- UltraTrac
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Minnesota
Cyanotic Congenital Heart Disease, Right Ventricular Outflow Tract Obstruction
RVOT Stenting Versus Surgical RV-PA Conduit in Cyanotic Adults
This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in…
- Trial name
- NCT07866911
- Volunteers
- 30 people
- Sponsor
- Assiut University
Congenital Heart Disease, Valvular Heart Disease
Echocardiographic Assessment of Valvular Dysfunction in Children With CHD
This cross-sectional study aims to assess the type and severity of valvular dysfunction by echocardiography in children with congenital heart disease.
- Trial name
- NCT07866924
- Volunteers
- 100 people
- Sponsor
- Assiut University