Clinical trials: Heart Defects, open to volunteers
Congenital Heart Disease, Congenital Vascular Disorder
Remote Monitoring in Pregnant Women With Congenital Heart Disease Using Wrist Wearables
Congenital heart disease (CHD) includes a wide variety of types of disease, including congenital abnormalities of the heart valves.
- Conditions
- Congenital Heart Disease, Congenital Vascular Disorder, Congenital Cardiomyopathy, Pregnancy Related
- Trial name
- NCT06818760
- Testing
- Masimo Smart Wristband
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
Hypoplastic Left Heart Syndrome
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).
- Trial name
- NCT06342999
- Testing
- Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter, Trek RX and Mini Trek RX Coronary Dilatation Catheter
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mauro H. Schenone
Congenital Heart Defects, Neurodevelopmental Disorder
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue.
- Trial name
- CATAMARAN Ped (NCT06442592)
- Testing
- Blood sampling, Assessment of neurodevelopment (CA), Assessment of neurodevelopment (Nantes)
- Where
- 5 sites in France
- Volunteers
- 1,206 people
- Sponsor
- Nantes University Hospital
Pulmonary Valve Insufficiency
Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
Aim of this study is to investigate the clinical safety of a novel pediatric heart valve.
- Trial name
- GECT (NCT05809856)
- Testing
- GrOwnValve - novel heart valve replacement approach
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Charite University, Berlin, Germany
Congenital Heart Disease in Adolescence
The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease
Congenital heart disease is one of the most common congenital defects with a high mortality and morbidity rate. Children with congenital heart disease step from pediatric care to adult care during adolescence.
- Trial name
- NCT06433401
- Testing
- Transitional care training with brochures, posters and slide training materials
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Ankara Yildirim Beyazıt University
AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
- Trial name
- NCT06830499
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 4 sites in China
- Volunteers
- 450 people
- Sponsor
- Xijing Hospital
Single-ventricle, Congenital Heart Disease
Fontan Fitness Trial
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention.
- Trial name
- NCT06918795
- Testing
- Digital Exercise Intervention
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Philadelphia
Bicuspid Aortic Valve
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves.
- Trial name
- NCT06153407
- Where
- South Korea
- Volunteers
- 240 people
- Sponsor
- Yonsei University
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal…
- Trial name
- NCT07431437
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
CHD - Congenital Heart Disease
Brain Ultrafast Ultrasound Imaging
Congenital heart defects affect 1 in 100 births in France, with rising prevalence due to better care. Despite improved survival, 40% of children post-surgery face neurological impairments, and some of them show brain lesions.
- Trial name
- Brain Ultrafas (NCT07299721)
- Testing
- Ultrafast ultrasound (UFUS)
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Bordeaux
Weight Gain, Body Mass Index
"Effects of High-Calorie Diets VS High-Calorie Formulas on Weight Gain in Children With Congenital Heart Disease "
This study is a randomized controlled trial designed to evaluate the effects of high-calorie diets and specialized nutritional formulas on weight gain and clinical outcomes in underweight children aged 1 to 5 years with…
- Conditions
- Weight Gain, Body Mass Index, Pediatric Nutrition, Congenital Heart Disease
- Trial name
- NCT07552688
- Testing
- High-Calorie Specialized Nutritional Formula, education program, High-Calorie Diet
- Where
- 2 sites in Iraq
- Volunteers
- 75 people
- Sponsor
- Aryan Najmadin Nasradin
Adult Congenital Heart Disease
Real-World Data on the Effects of Cardiac Resynchronization Therapy in Adult Patients With Congenital Heart Disease
This study aims to evaluate the real-world effects of cardiac resynchronization therapy (CRT) in adult patients with congenital heart disease (ACHD).
- Trial name
- RECORD-CHD (NCT06969924)
- Testing
- Cardiac resynchronization therapy
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Leiden University Medical Center
Epilepsy (treatment Refractory)
Percutaneous Repair for Drug - Resistant Epilepsy by Intervention of Closing the Patent Foramen Ovale（PREDICT-PFO Trial）
Patent foramen ovale (PFO) is the most common cause of right-to-left shunt (RLS) in the adult heart, with a prevalence of approximately 25% in the general population.
- Trial name
- PREDICT-PFO (NCT06863350)
- Testing
- patent foramen ovale closure
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Sichuan University
Congenital Heart Disease (CHD)
Cord Clamping Among Neonates With Congenital Heart Disease
The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD).
- Trial name
- CORD-CHD (NCT06153459)
- Testing
- Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds, Umbilical Cord Milking
- Where
- 21 sites in United States, Canada
- Volunteers
- 500 people
- Sponsor
- Carl Backes, MD
Heart Defects, Congenital, Mental Health Issue
Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects
The aim of the Mind the Heart study is to document the feasibility of an online parent/child administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD).
- Trial name
- Mind the Heart (NCT05709470)
- Testing
- No-intervention
- Where
- Denmark
- Volunteers
- 4,800 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Congenital Heart Disease, Aortic Valve Stenosis
Effect of Fetal Aortic Valvuloplasty on Outcomes
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Trial name
- FASSprosp (NCT05386173)
- Testing
- Fetal aortic balloon dilatation
- Where
- 13 sites in United States, Austria and 6 more
- Volunteers
- 200 people
- Sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
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.
Velocardiofacial Syndrome, Williams Syndrome
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to…
- Conditions
- Velocardiofacial Syndrome, Williams Syndrome, Fragile X Syndrome
- Trial name
- VCFS (NCT00768820)
- Testing
- methylphenidate, fluoxetin, risperidone
- Where
- Israel
- Volunteers
- 400 people
- Sponsor
- The Chaim Sheba Medical Center
Cardiomyopathies, Heart Diseases
PKP2-ACM Natural History Study
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
- Conditions
- Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Genetic Diseases
- Trial name
- NCT06644742
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 36 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Congenital Heart Disease (CHD)
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe.
- Trial name
- BASICS-Kids (NCT06882772)
- Testing
- 2 mL SunButyrate-TG, 4 mL SunButyrate-TG
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of Nebraska