Clinical trials: Heart Defects, Congenital, open to volunteers
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
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
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, 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
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
Normal and Abnormal Cardiovascular Physiology
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Background: Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs.
- Trial name
- NCT03581318
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Heart Defect, Congenital, Executive Dysfunction
Executive Function Intervention for Children With Complex Congenital Heart Disease
Children with complex congenital heart disease (cCHD) nowadays survive thanks to medical advances into their teenage years and adulthood. However, many of them have difficulties with so-called executive functions.
- Trial name
- E-Fit Heart (NCT07692958)
- Testing
- E-Fit Intervention
- Where
- Switzerland
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Bea Latal
Congenital Heart Disease (CHD), Postoperative Sleep
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children.
- Trial name
- NCT07854145
- Testing
- Starry-Sky Projection, Conventional Lighting, Maternal Voice
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease, Telerehabilitation
The Effect of Telerehabilitation Exercises in Children With Congenital Heart Disease
This study aims to investigate the effects of functional inspiratory muscle training on physical performance and quality of life in pediatric patients with congenital heart disease.
- Conditions
- Congenital Heart Disease, Telerehabilitation, Functional Inspiratory Muscle Training
- Trial name
- CHD (NCT07854171)
- Testing
- Inspiratory Muscle Training, Functional Inspiratory Muscle Training
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people
- Sponsor
- Izmir Democracy University
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Hypoxemia, Skin Pigment
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic.
- Conditions
- Hypoxemia, Skin Pigment, Congenital Heart Disease
- Trial name
- NCT06575270
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Congenital Heart Disease, Unfractionated Heparin
Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
This study aims to compare the accuracy of two different blood sampling methods from a central venous catheter (CVC) for measuring anti-Xa activity in children receiving unfractionated heparin (UFH) from this CVC.
- Conditions
- Congenital Heart Disease, Unfractionated Heparin, Anti Xa Activity
- Trial name
- COMPAXE-HNF (NCT07365670)
- Testing
- blood sampling for measuring anti-Xa activity, measurement of anti-XA activity
- Volunteers
- 22 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Congenital Heart Disease (CHD), Artifical Intelligence
AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital…
- Conditions
- Congenital Heart Disease (CHD), Artifical Intelligence, Screening, Cardiac Auscultation
- Trial name
- NCT07830251
- Testing
- AI-Assisted Cardiac Auscultation
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Kun Sun