Clinical trials: Cardiac Defects
Brain Injuries, Congenital Heart Disease
Protecting Brains and Saving Futures - the PBSF Protocol
Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care.
- Conditions
- Brain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
- Trial name
- PBSF (NCT03786497)
- Where
- 2 sites in Brazil
- Volunteers
- 2,268 people
- Sponsor
- Protecting Brains Saving Futures
Patent Ductus Arteriosus (PDA)
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
- Trial name
- NCT00583596
- Testing
- Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
- Where
- 24 sites in United States
- Volunteers
- 436 people
- Sponsor
- Abbott Medical Devices
Coarctation of Aorta
Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants
The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.
- Trial name
- NCT02835703
- Testing
- Surgical repair of coarctation of aorta
- Where
- Russia
- Volunteers
- 45 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Congenital Heart Disease, Bicuspid Aortic Valve
Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve
Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the heart to the body) are not formed right.
- Trial name
- NCT00412386
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Emory University
Congenital Heart Disease in Children
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent.
- Trial name
- COMPASS (NCT05268094)
- Testing
- Ductal Arterial Stent, Systemic-to-Pulmonary Artery Shunt
- Where
- 24 sites in United States, Canada
- Volunteers
- 300 people
- Sponsor
- Carelon Research
DiGeorge Anomaly, Complete DiGeorge Anomaly
Phase I/II Thymus Transplantation With Immunosuppression #950
The study purpose is to determine if cultured thymus tissue implantation (CTTI) (previously described as transplantation) with tailored immunosuppression based on the recipient's pre-implantation T cell population is a safe and…
- Conditions
- DiGeorge Anomaly, Complete DiGeorge Anomaly, Complete Atypical DiGeorge Anomaly, Complete DiGeorge Syndrome
- Trial name
- #950 (NCT00579527)
- Testing
- Cultured Thymus Tissue for Implantation (CTTI), Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation, Blood Draw
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Sumitomo Pharma Switzerland GmbH
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
Adult Congenital Heart Disease, Heart Failure
Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).
- Trial name
- EmpaCHD (NCT06260059)
- Testing
- Empagliflozin 10 MG
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Anita Saraf
Heart Septal Defects, Ventricle, Heart Defects, Congenital
Genes Causing Ebstein's Anomaly
This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid valve of the heart and try to identify the genetic origins of the disease.
- Conditions
- Heart Septal Defects, Ventricle, Heart Defects, Congenital, Double Outlet Right Ventricle, Truncus Arteriosus, Persistent
- Trial name
- NCT00497705
- Where
- 3 sites in United States, Belarus and 1 more
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Congestive Heart Failure, Congestive Heart Failure
A Clinical Study Used to Estimate Central Venous Pressure Non-invasively Using Occlusion Pressure
The purpose of this study is to collect different measurements using a method called peripheral venous pressure (PVP). PVP checks the pressure in the veins in the arms or legs.
- Trial name
- CV-PRO (NCT07583680)
- Volunteers
- 30 people
- Sponsor
- Le Bonheur Children's Hospital
Congenital Heart Defects
An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease
The purpose of this study is to understand how having a heart problem affects development,quality of life, and family life in young children and their families.
- Trial name
- NCT01567579
- Where
- United States
- Volunteers
- 928 people
- Sponsor
- Medical College of Wisconsin
Transposition Great Arteries, Executive Dysfunction
The Boston Circulatory Arrest Study: Antecedents and Correlates of Well-Being in Adults With Congenital Heart Disease
In the landmark Boston Circulatory Arrest Study, neurologic and developmental status was measured following infant heart surgery and then prospectively at ages 1, 2.5, 4, 8, and 16 years, with findings of significant…
- Trial name
- BCAS-Adult (NCT03073122)
- Testing
- Brain MRI, neurocognitive and psychological testing
- Where
- United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Congenital Heart Defects
Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease
Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population.
- Trial name
- HIIT-GUCH (NCT02632253)
- Testing
- HIIT, MICE
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Patent Foramen Ovale, Atrial Septal Defect
Lifetech CeraFlex™ Post-Market Surveillance Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™…
- Conditions
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT02621528
- Testing
- CeraFlex
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Congenital Heart Disease
Fearless Physical Activity: Getting and Keeping Ontarians With Congenital Heart Disease Active
"Fearless Physical Activity" are fun, physical literacy events where people with congenital heart disease (CHD) and sport/recreation leaders can do community-based sport/recreation opportunities "without fear" (i.e., appropriate…
- Trial name
- Fearless (NCT02990754)
- Testing
- Physical activity education
- Where
- Canada
- Volunteers
- 260 people
- Sponsor
- Children's Hospital of Eastern Ontario
Time Needed to Achieve a Successful Cannulation of the Femoral Artery in Pediatric Cardiac Surgery
Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery
The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.
- Trial name
- NCT02183857
- Testing
- Ultrasound, Landmark
- Where
- Lebanon
- Volunteers
- 106 people
- Sponsor
- American University of Beirut Medical Center
Idiopathic Pulmonary Arterial Hypertension, Cardiomyopathy
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing
The primary purpose of this study is to compare the number of participants with reversible pulmonary hypertension (vasoreactivity) due to nitric oxide for inhalation and oxygen as compared to 100% oxygen.
- Trial name
- NCT00626028
- Testing
- Nitric Oxide for inhalation, Oxygen, Nitric Oxide plus Oxygen
- Where
- 18 sites in United States, France and 3 more
- Volunteers
- 136 people
- Sponsor
- Mallinckrodt
Hypoplastic Left Heart Syndrome
SVRII Family Factors Study
The purpose of this study is to learn about the relationship between family factors and developmental and psychosocial outcomes in children with congenital heart disease at 6 years of age.
- Trial name
- NCT01582529
- Where
- 11 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Medical College of Wisconsin
Atrial Septal Defect Secundum
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
- Trial name
- ASO 522 (NCT02353351)
- Testing
- atrial septal occluder
- Where
- 65 sites in United States
- Volunteers
- 602 people
- Sponsor
- Abbott Medical Devices
Long QT Syndrome, Cardiac Repolarization
Effect of Beta-blocker Therapy on QTc Response in Exercise and Recovery in Normal Subjects
Background. In congenital long QT syndrome type 1 (LQT1), episodes of ventricular tachycardia are usually triggered by exercise and can be prevented in most patients by beta-blocker therapy.
- Trial name
- NCT00588965
- Testing
- Propranolol LA
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- MetroHealth Medical Center
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