Clinical trials: Congenital Heart Defect
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
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
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Low T3 Syndrome
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass.
- Trial name
- NCT01780584
- Testing
- Oral T3 Low dose, Oral T3 high dose
- Where
- Indonesia
- Volunteers
- 45 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Congenital Heart Disease, Heart Failure
Spironolactone in Adult Congenital Heart Disease
The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function.
- Conditions
- Congenital Heart Disease, Heart Failure, Endomyocardial Fibrosis
- Trial name
- NCT01069510
- Testing
- Spironolactone 25mg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Oregon Health and Science University
Congenital Heart Disease
Influence of Genetic Polymorphisms on Ventricular Structure and Function in Patients With Single Ventricle Anatomy
There are many kids born with congenital heart disease. Some of these defects may lead to the formation of a single ventricle (the heart having only one pumping chamber).
- Trial name
- NCT00165984
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Emory University
Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
- Conditions
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect
- Trial name
- T-NOX (NCT04452188)
- Testing
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- University of Michigan
Congenital Heart Disease, Single Ventricle
Improving Functional Capacity in Fontan Patients Through Inspiratory Muscle Training
Mechanisms that typically result in increased cardiac output, such as inotropic support, increased heart rate, and decreased afterload, have a blunted effect in Fontan circulation.
- Trial name
- NCT01977222
- Testing
- THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Boston Children's Hospital
Congenital Heart Disease, Disorder of Fetus or Newborn
Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).
- Trial name
- NCT00934843
- Testing
- methylprednisolone (IVMP), methylprednisolone (two doses IVMP)
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Medical University of South Carolina
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Erythropoetin Neuroprotection for Neonatal Cardiac Surgery
Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning…
- Conditions
- Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Aortic Arch Hypoplasia or Interruption
- Trial name
- NCT00513240
- Testing
- Erythropoetin, Normal saline
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Baylor College of Medicine
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
Congenital Heart Defects
Congenital Heart Adolescents: Program of Transition Evaluation Research
The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this…
- Trial name
- CHAPTER (NCT01286480)
- Testing
- Clinic-based Educational Intervention
- Where
- Canada
- Volunteers
- 66 people
- Sponsor
- University of Alberta
Congenital Disorders
Spironolactone in Patients With Single Ventricle Heart
Ultrasound is a technique that can provide images of the blood vessels such as arteries. The size of the arteries, such as the main blood vessel in the arm, can change under different conditions.
- Trial name
- NCT00211081
- Testing
- Spironolactone (drug)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Emory University
Atrial Septal Defect
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
- Trial name
- NCT00650936
- Testing
- AMPLATZER Septal Occluder
- Where
- 51 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Congenital Heart Disease
Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"
The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.
- Trial name
- NCT01063712
- Testing
- Nit-Occlud® PDA-R
- Where
- Bolivia
- Volunteers
- 29 people
- Sponsor
- pfm S.R.L.
Congenital Heart Disease
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD.
- Trial name
- HEARTPrep (NCT05129631)
- Testing
- HEARTPrep
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nemours Children's Clinic
Circulatory Perfusion Disorder, Congenital Heart Disease
Early Use of Vasopressin in Post-Fontan Management
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric…
- Conditions
- Circulatory Perfusion Disorder, Congenital Heart Disease, Single-ventricle
- Trial name
- VAMP (NCT03088345)
- Testing
- Vasopressin, Arginine
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin