Clinical trials: Cardiac Defects
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Transposition of Great Vessels
A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently.
- Trial name
- CELSIOR-TGV (NCT04616222)
- Testing
- CELSIOR® group, Saint-Thomas group
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon
Ductus Arteriosus, Patent
Alternative Paracetamol Treatments for the Neonate With a hsPDA
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended.
- Trial name
- NCT03604796
- Testing
- Rectal Solution, Intravenous Infusion
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Shaare Zedek Medical Center
Adult Congenital Heart Disease
Observational Cohort Study of Adult Patients With Congenital Heart Disease
The aim of this retrospective and prospective single-center observational study is to evaluate the correct management of adult patients with congenital heart diseas (ACHD), based on the experience of a reference center such as…
- Trial name
- ACHD-BO (NCT06769529)
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Congenital Heart Disease (CHD), Postoperative Sleep
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
The goal of this clinical trial is to determine whether a starry-sky projection affects sleep during the early period after cardiac surgery in young children.
- Trial name
- NCT07854145
- Testing
- Starry-Sky Projection, Conventional Lighting, Maternal Voice
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
Heart Septal Defects, Ventricular
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with…
- Trial name
- NCT00583791
- Testing
- Device closure with the AMPLATZER Muscular VSD Occluder
- Where
- 11 sites in United States
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Single-ventricle, Pulmonary Hypertension
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance.
- Conditions
- Single-ventricle, Pulmonary Hypertension, Univentricular Heart
- Trial name
- VU-INHIB (NCT03997097)
- Testing
- Sildenafil
- Sponsor
- University Hospital, Montpellier
Coarctation of the Aorta
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
This study is designed as a prospective, multicenter, non-randomized, single arm study to assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for stent implantation in coarctations of the aorta.
- Trial name
- NCT00978952
- Testing
- Large Diameter Advanta™ V12 Covered Stent
- Where
- 9 sites in Australia, Brazil and 5 more
- Volunteers
- 70 people
- Sponsor
- Atrium Medical Corporation
Congenital Heart Defect
Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.
This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects…
- Trial name
- NCT03297658
- Testing
- electro-acupuncture (EA)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- West Virginia University
Patent Foramen Ovale (PFO)
Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale
A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale.
- Trial name
- NCT07726927
- Testing
- Patent Foramen Ovale Suture System, Amplatzer PFO Occluder
- Volunteers
- 244 people
- Sponsor
- Shenzhen Bihe Medical Co., Ltd
Bundle-Branch Block, Heart Septal Defects, Ventricular
Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent.
- Trial name
- NCT01480908
- Testing
- Echocardiography at rest, Echocardiography during exercise, MRI at rest
- Where
- Denmark
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Congenital Cardiac Defects
Hemoglobin Trend in Neonates and Toddlers Post Cardiac Surgery
Many toddlers and children are released home with relatively low hemoglobin levels following cardiac surgery, and with no careful follow up, at an age at which anemia is common.
- Trial name
- NCT02686255
- Testing
- complete blood count
- Where
- Israel
- Volunteers
- 250 people
- Sponsor
- Rabin Medical Center
Long QT Syndrome
Multicenter Evaluation of Children and Young Adults With Genotype Positive Long QT Syndrome
The purpose of the study is to provide comprehensive follow-up in patients with Long QT Syndrome (LQTS) and gain additional information regarding genotype-phenotype correlation and effective management and treatment options.
- Trial name
- NCT01705925
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Pediatrix
Univentricular Heart
Aesculus Hippocastanum L. on Fontan Circulation
Patients after the Fontan operation at a single institution will be randomized to receive a standardized extract of Aesculus hippocastanum L. (horse chestnut) or placebo for 4 months in a crossover clinical trial.
- Trial name
- NCT04035317
- Testing
- Aesculus Hippocastanum / Horse Chestnut
- Where
- Brazil
- Sponsor
- Casa Espirita Terra de Ismael
Congenital Cardiomyopathy
Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease
This study will invite parents of children who underwent surgical treatment for congenital heart disease to complete a validated proxy-report questionnaire assessing executive and psychosocial functioning.
- Trial name
- NEUROTECH (NCT07437261)
- Testing
- Questionnaire
- Where
- 2 sites in France
- Volunteers
- 155 people
- Sponsor
- University Hospital, Toulouse
Congenital Heart Defect
Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery
It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short…
- Trial name
- NCT02884973
- Volunteers
- 30 people
- Sponsor
- University Hospital, Strasbourg, France
Congenital Heart Disease
Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has…
- Trial name
- NCT02567786
- Testing
- Surgery with CPB, Fresh Frozen Plasma, Plasmalyte
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Heart Defects, Congenital
Accelerated Aging in Newborns and Adults With Congenital Heart Disease
Many childhood-onset diseases used to be lethal. Improved life expectancy yield that most patients can survive into adulthood, to date.
- Trial name
- AccelerAGE (NCT05667870)
- Where
- 2 sites in Belgium
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Noonan Syndrome
A Study of Vosoritide in Children With Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment
The purpose of this study in children with Noonan syndrome is to evaluate the effect of 3 doses of vosoritide on growth as measured by AGV after 6 months of treatment.
- Trial name
- NCT06668805
- Testing
- Vosoritide Injection
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 30 people
- Sponsor
- BioMarin Pharmaceutical