Clinical trials: Heart Defects
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
Congenital Heart Disease
Precision Medicine in the CICU: Identifying Proteomic Biomarkers
Congenital Heart disease (CHD) is a leading cause of childhood death. Substantial morbidity and mortality relates to the postoperative course.
- Trial name
- NCT06642662
- Testing
- Somascan 5.0
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Children's Hospital
Heart Failure, Cardiac Imaging Techniques
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for…
- Conditions
- Heart Failure, Cardiac Imaging Techniques, Congenital Heart Defects
- Trial name
- NCT03822442
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Children's National Research Institute
Congenital Heart Disease, Postoperative Pulmonary Complications
Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay.
- Conditions
- Congenital Heart Disease, Postoperative Pulmonary Complications, Acute Lung Injury
- Trial name
- PLICS (NCT07499154)
- Testing
- Lidocaine %2 ampoule, Normal Saline (0.9% NaCl)
- Where
- China
- Volunteers
- 320 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Congenital Heart Disease, Thiamine Deficiency
The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease
Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of…
- Conditions
- Congenital Heart Disease, Thiamine Deficiency, Patent Ductus Arteriosus, Ventricular Septal Defect
- Trial name
- NCT06298344
- Testing
- Thiamine
- Where
- Indonesia
- Volunteers
- 86 people
- Sponsor
- Universitas Sumatera Utara
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul
Deglutition Disorders in Children, Congenital Heart Disease
Speech Therapy Online Approach for Children With Congenital Heart Desease in Pre and Post Surgical Period
The goal of this clinical trial is to test the results of a protocoled speech therapy online intervention in children with congenital heart disease aged between 0 and 12 months old, who feeds tube only.
- Trial name
- NCT07481565
- Testing
- Oral motor intervention
- Where
- 2 sites in Brazil
- Volunteers
- 20 people
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
Atrial Septal Defect
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
- Trial name
- ASSURED (NCT02985684)
- Testing
- GORE® CARDIOFORM ASD Occluder
- Where
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
Congenital Heart Defect
A Feasibility Study of Physical Activity After Surgical or Catheterization Intervention
This feasibility study will assess whether a 6-month, home-based, parent-led physical activity program, completed after surgical or catheterization treatment, enables young children with congenital heart defects (CHD) to achieve…
- Trial name
- NCT04619745
- Testing
- Individualized Home and Play-Based Physical Activity Plans
- Where
- Canada
- Volunteers
- 43 people
- Sponsor
- Children's Hospital of Eastern Ontario
Cardiac Surgery Requiring Cardiopulmonary Bypass, Brain Injury
The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
Patients born with heart defects often undergo surgical procedures on a heart lung machine. With improvements in medical and surgical management, their survival has significantly improved, but their brain insult has not been paid…
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass, Brain Injury, Congenital Heart Defect
- Trial name
- NCT06899971
- Testing
- Collecting discarded blood samples
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Atrial Septal Defect (ASD)
A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment.
- Trial name
- PANNA-ASD (NCT07054541)
- Testing
- Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention
- Where
- China
- Volunteers
- 666 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Adult Congenital Heart Disease, Pulmonary Hypertension
Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of…
- Conditions
- Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
- Trial name
- HIBR-ACHD (NCT07477197)
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
Pediatric ALL, Congenital Heart Disease
Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during…
- Conditions
- Pediatric ALL, Congenital Heart Disease, Heart Transplantation
- Trial name
- NCT06325280
- Testing
- Exercise cardiac MRI Assessment, Cardiopulmonary Exercise Test
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- University of Alberta
Congenital Heart Disease (CHD), Cardiopulmonary Bypass
Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery
The objective is to investigate a goal-oriented postoperative circulation management strategy centered on "oxygen metabolism balance".
- Conditions
- Congenital Heart Disease (CHD), Cardiopulmonary Bypass, Children, Oxygen Delivery
- Trial name
- NCT06747546
- Testing
- "goal-directed" treatment strategy based on oxygen supply and consumption balance, Conventional Treatment group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Children's Hospital of Fudan University
Atrial Arrhythmia, Atrial Tachycardia
ATrial Tachycardia PAcing Therapy in Congenital Heart
Congenital heart disease (CHD) affects approximately 1% of newborns in the US, with 25% of those affected having critical conditions requiring open heart surgery within one year of birth.
- Conditions
- Atrial Arrhythmia, Atrial Tachycardia, Congenital Heart Disease, Pacemaker Re-Entrant Tachycardia
- Trial name
- AT-PATCH (NCT03209583)
- Testing
- Medtronic
- Where
- 15 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Ian Law
Congenital Heart Disease, Congenital Heart Disease in Adolescence
The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease
Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in adult cardiology practices. This population is vulnerable to gaps in care, particularly as they graduate from the pediatric to adult…
- Trial name
- READYorNot CHD (NCT04463446)
- Testing
- Use of the CHD app, Nurse-led intervention
- Where
- Canada
- Volunteers
- 207 people
- Sponsor
- University of Alberta
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions.
- Trial name
- NCT07326735
- Testing
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Where
- 2 sites in Burma, Malaysia
- Volunteers
- 360 people
- Sponsor
- Frisch Medical Device Private Limited
Heart Septal Defects, Atrial, Atrial Septal Defect
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
- Trial name
- NCT03601039
- Testing
- Absnow Absorbable ASD Closure System
- Where
- 14 sites in China
- Volunteers
- 165 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury.
- Trial name
- NCT07424976
- Testing
- Observational study: blood analisys, EEG, MRI
- Where
- Slovenia
- Volunteers
- 30 people
- Sponsor
- University Medical Centre Ljubljana