Clinical trials: Complex Congenital Heart Defect
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
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
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
Congenital Heart Disease, Pulmonary Arterial Hypertension
4DFlow Magnetic Resonance Imaging in Patients With Pulmonary Hypertension Associated With Congenital Heart Disease
Congenital heart disease is the most common congenital anomaly. The life expectancy of children with congenital heart disease has increased considerably in recent years.
- Trial name
- 4DFlowHTAPCC (NCT03928002)
- Testing
- 4D Flow magnetic resonance imagery, Cardiac catheterization
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
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
Congenital Heart Disease (CHD), Eisenmenger Syndrome
Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome
The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome.
- Conditions
- Congenital Heart Disease (CHD), Eisenmenger Syndrome, PAH
- Trial name
- CHASE (NCT07498803)
- Testing
- Sotatercept
- Volunteers
- 40 people
- Sponsor
- Philipps University Marburg
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 (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
Eisenmenger Syndrome
Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome
The Eisenmenger syndrome corresponds to the most advanced form of pulmonary arterial hypertension associated with congenital heart disease.
- Trial name
- NCT05611268
- Testing
- Pentoxifylline
- Where
- Brazil
- Volunteers
- 48 people
- Sponsor
- University of Sao Paulo General Hospital
Complex Congenital Heart Defect
Neurodevelopment in Infants With Complex Congenital Heart Defects
The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently…
- Trial name
- NCT03104751
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Ohio State University
Eisenmenger Complex, Pulmonary Hypertension
Six Minutes Walk Test and Shuttle Walk Test in Eisenmenger Syndrome
The purpose of this study is to verify the applicability Six minutes walk test and Shuttle walk test in assessing functional capacity in patients with Eisenmenger Syndrome.
- Conditions
- Eisenmenger Complex, Pulmonary Hypertension, Congenital Heart Defects
- Trial name
- NCT02752399
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Federal University of São Paulo
Eisenmenger Syndrome, Congenital Heart Disease
Sleep-disordered Breathing in Eisenmenger Syndrome
Sleep-disordered breathing (SDB) is a wellknown comorbidity in cardiovascular disease. Knowledge about SDB in adult congenital heart disease is limited.
- Conditions
- Eisenmenger Syndrome, Congenital Heart Disease, Sleep-disordered Breathing
- Trial name
- NCT02614417
- Testing
- Polysomnography
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Pulmonary Arterial Hypertension, Congenital Heart Disease
Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease
Pulmonary arterial hypertension (PAH), or high blood pressure in the lungs, is common in patients with congenital heart disease.
- Conditions
- Pulmonary Arterial Hypertension, Congenital Heart Disease, Eisenmenger's Syndrome
- Trial name
- NCT01319045
- Testing
- Iloprost
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, Los Angeles
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
Eisenmenger Syndrome
Bosentan in Treatment of Pulmonary Arterial Hypertension
Eisenmenger's syndrome presents as a severe clinical picture of polymorbidity that constitutes a great burden at the individual as well as the familial and social level.
- Trial name
- NCT00266162
- Testing
- Bosentan administration
- Where
- 8 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Competence Network for Congenital Heart Defects