Clinical trials: Complex Congenital Heart Defect
Pulmonary Arterial Hypertension, Eisenmenger Syndrome
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated…
- Trial name
- NCT01397110
- Testing
- respiratory and exercise therapy
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Heidelberg University
Congenital Heart Disease (CHD), Complex Congenital Heart Disease
Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease
This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.
- Conditions
- Congenital Heart Disease (CHD), Complex Congenital Heart Disease, Congenital Heart Disease in Children
- Trial name
- NCT06912412
- Testing
- Community-based supervised remote cardiac rehabilitation, Home-based cardiac rehabilitation program
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Seoul National University Hospital
Single Ventricle Physiology
Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation…
- Trial name
- NCT02995577
- Testing
- Feeding tolerant, Feeding intolerant, Necrotizing enterocolitis
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center, Houston
Congenital Disorders
Eisenmenger's Syndrome in Adults With CHD
Review the outcome of treatment with endothelin receptor antagonists (bosentan or sitaxsetan) alone or in combination with Sildenafil (a PDE-5 inhibitor) in adult patients with pulmonary hypertension due to congenital heart…
- Trial name
- NCT00266903
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Children's Healthcare of Atlanta
Cardiac Surgery, Acute Kidney Injury
Acute Normovolemic Hemodilution in Complex Cardiac Surgery
Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes.
- Conditions
- Cardiac Surgery, Acute Kidney Injury, Congenital Heart Disease, Aortic Surgery
- Trial name
- ANH (NCT05049590)
- Testing
- Acute normovolemic hemodilution (ANH)
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- University of California, Los Angeles
Double Outlet Right Ventricle
Surgical Planning for Reconstruction of Complex Heart Defects
The purpose of this study is to utilize cardiac imaging data acquired as part of the standard of care for these patients, such as MRI, 3D echo, and CT, and existing 3D reconstruction protocols to assess the feasibility of using…
- Trial name
- NCT00972608
- Testing
- Anatomic Reconstruction and Surgical Planning
- Where
- 2 sites in United States
- Volunteers
- 66 people
- Sponsor
- Emory University
Congenital Disorders
Percutaneous Interventions in Adults With CHD
The primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex…
- Trial name
- NCT00266916
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Children's Healthcare of Atlanta
Congenital Heart Disease, Complex Congenital Heart Disease
A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease
The goal of this observational study is to learn about recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD), build a comprehensive data platform for CCHD care across a person's whole life, and…
- Conditions
- Congenital Heart Disease, Complex Congenital Heart Disease, Surgery (Cardiac), Perioperative Care
- Trial name
- NCT07524998
- Where
- China
- Volunteers
- 3,000 people
- Sponsor
- China National Center for Cardiovascular Diseases
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Complex Congenital Heart Disease
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD.
- Trial name
- CINC (NCT04733378)
- Testing
- Peri-operative neurological monitoring
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Heart Defects, Congenital, Pediatrics
CHAMP App Cardiac Study and Repository
This is a multi-site research study with an optional research repository that will consist of clinically derived data and photographic or video images of patients in the home setting with complex health conditions to evaluate the…
- Trial name
- CHAMP (NCT06034392)
- Testing
- CHAMP App
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Lori Erickson
Congenital Heart Defects, Inherited Cardiac Arrhythmias
Healthy Lifestyles for Children With Complex Heart Problems
Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to…
- Conditions
- Congenital Heart Defects, Inherited Cardiac Arrhythmias, Cardiomyopathy
- Trial name
- ReACH (NCT01785498)
- Testing
- Supplementary resources
- Where
- Canada
- Volunteers
- 64 people
- Sponsor
- Children's Hospital of Eastern Ontario
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Disease
Role of Terminal Warm Blood Cardioplegia as Myocardial Protection in the Use of Histidine-Tryptophan-Ketoglutarate Cardioplegia in Complex Congenital Heart Surgery
Terminal warm blood cardioplegia (TWBC) has been shown to enhance myocardial protection in adult patients. Even in pediatric patients, the use of cold blood cardioplegia followed by administration of TWBC will provide…
- Trial name
- NCT02618824
- Testing
- Histidine Tryptophan Ketoglutarate Solution, Terminal Warm Blood Cardioplegia
- Where
- Indonesia
- Volunteers
- 110 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Heart Defects, Congenital
Rehabilitation in Patients With Congenital Heart Disease
Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life.
- Trial name
- CARE-GUCH (NCT01463800)
- Testing
- Structured exercise training
- Where
- 4 sites in Spain, Switzerland
- Volunteers
- 28 people
- Sponsor
- University Hospital, Basel, Switzerland
Childhood Cancer, Cerebral Palsy
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity
This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of…
- Conditions
- Childhood Cancer, Cerebral Palsy, Chronic Lung Disease, Congenital Heart Disease
- Trial name
- GoalKeeper (NCT03620071)
- Testing
- GoalKeeper, Standard Care
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Stanford University
Growth Delay
Outpatient Exclusive Human Milk Diet for Single Infant With Complex Congenital Heart Disease
A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and…
- Trial name
- NCT04231630
- Testing
- Prolacta
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Texas at Austin
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Congenital Heart Disease in Children, Hypoxia
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart…
- Conditions
- Congenital Heart Disease in Children, Hypoxia, Neurodevelopmental Disorders, Complex Congenital Heart Disease
- Trial name
- NCT05767385
- Testing
- Single Arm, Neonatal Neurobehavioral Scale
- Where
- 5 sites in United States
- Volunteers
- 104 people
- Sponsor
- University of Utah
Heart Defects, Congenital
Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal…
- Trial name
- NCT02781545
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Wake Forest University Health Sciences