Clinical trials: Defect, Congenital Heart
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Familial Hypercholesterolemia, Lipid Disorder
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients.
- Trial name
- FHCanada (NCT02009345)
- Where
- Canada
- Volunteers
- 6,000 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Patent Ductus Arteriosus
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01544972
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Right Ventricular Outflow Tract Absent, Congenital Heart Disease
New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract
Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of…
- Conditions
- Right Ventricular Outflow Tract Absent, Congenital Heart Disease, Pulmonary Valve Disorders
- Trial name
- NCT04152967
- Testing
- new-designed PTFE valved conduits, Bovine jugular vein valved conduits
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Congenital Heart Disease, Single-ventricle
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery.
- Conditions
- Congenital Heart Disease, Single-ventricle, Thrombosis
- Trial name
- EVmiRNA (NCT06434207)
- Testing
- Collecting discarded blood samples
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
Bicuspid Aortic Valve Disease, Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve
International Bicuspid Aortic Valve Consortium (BAVCon)
Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population.
- Trial name
- BAVCon (NCT01980797)
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 6,464 people
- Sponsor
- Boston University
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
Migraine Disorders, Patent Foramen Ovale
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura.
- Conditions
- Migraine Disorders, Patent Foramen Ovale, Right-to-Left Shunt, Cardiac
- Trial name
- NCT07170176
- Testing
- Percutaneous Patent Foramen Ovale Closure, No Intervention
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Congenital Heart Disease in Children, Neurologic Complication
Erector Spinae Plane Block in Congenital Heart Disease Patients
Pediatric cardiac patients undergoing surgical anesthesia are at an increased risk of poor neurologic outcome (20-50%). Unattenuated anesthetic exposure and pain contributes to physiologic perturbations that may increase…
- Trial name
- NCT04158024
- Testing
- Erector Spinae Plane Block
- Volunteers
- 150 people
- Sponsor
- Stanford University
Eisenmenger Syndrome, Pulmonary Arterial Hypertension of Congenital Heart Disease
A Study of Sotatercept for Patients With Eisenmenger Syndrome or Unrepaired Shunt-Associated Pulmonary Arterial Hypertension Resistant to Vasodilator Therapy
What is this study about? This study will test whether adding sotatercept to usual medicines for pulmonary arterial hypertension (PAH) can help adults who have PAH due to unrepaired congenital heart defects (atrial or ventricular…
- Trial name
- SuMILE (NCT07356778)
- Testing
- Sotatercept, vasodilator-based PAH therapy
- Where
- 10 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Kazuya Hosokawa
Hemoglobin, Cerebral Oxygenation
Observational Data Collection for Blood Hemoglobin Algorithm Validation in Pediatrics
This study will enroll children and young adults who are scheduled to undergo planned heart surgery or a heart catheterization procedure while under general anesthesia.
- Conditions
- Hemoglobin, Cerebral Oxygenation, Congenital Heart Disease
- Trial name
- NCT07706140
- Testing
- Noninvasive hemoglobin monitoring
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Children's Hospital
Heart Defects, Congenital, Critical Illness
Leuven Growing Into Deficit Follow-up Study
The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old…
- Conditions
- Heart Defects, Congenital, Critical Illness, Mental Processes, Child
- Trial name
- Leuven-GID (NCT01632813)
- Where
- Belgium
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- KU Leuven
Ventricular Septal Defect
Immune Heterogeneity Before and After Cardiopulmonary Bypass in Children
The goal of this observational study is to learn about functional heterogeneity of immune cells before and after cardiopulmonary bypass (CPB) in children with congenital heart disease (CHD).
- Trial name
- NCT06214182
- Where
- China
- Volunteers
- 3 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Dilated Cardiomyopathy (DCM), Heart Failure
Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of end-stage dilated cardiomyopathy and provide a new method…
- Trial name
- NCT06902896
- Testing
- FAP immunosuppressive CAR-DC
- Where
- China
- Volunteers
- 43 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
Congenital Heart Disease (CHD), Hypoxic Encephalopathy
Early Detection of Brain Injury After Congenital Heart Surgery in Infants
Infants with congenital heart disease undergoing cardiac surgery with extracorporeal circulation are at risk for perioperative hypoxic-ischaemic brain injury.
- Trial name
- NCT07424976
- Testing
- Observational study: blood analisys, EEG, MRI
- Where
- Slovenia
- Volunteers
- 30 people
- Sponsor
- University Medical Centre Ljubljana
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Arrhythmia, Sudden Cardiac Death
Electrophysiological Phenotyping Of Patients at Risk of Ventricular Arrhythmia and Sudden Cardiac Death
Obesity, rheumatoid arthritis (RA) and gene-specific dilated cardiomyopathy (DCM) are common medical conditions. Small-scale studies have shown that these are associated with proarrhythmic changes on 12-lead electrocardiogram…
- Conditions
- Arrhythmia, Sudden Cardiac Death, Cardiomyopathy, Dilated, Obesity
- Trial name
- EPORVA (NCT03910725)
- Testing
- Electrocardiographic imaging
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Pregnancy Complication, Aortic Dissection
PregnAncy-Related Aortic DISsEction in China
A multicenter observational study on pregnancy-related aortic dissection
- Conditions
- Pregnancy Complication, Aortic Dissection, Marfan Syndrome, Loeys-Dietz Syndrome
- Trial name
- PARADISE (NCT07672210)
- Testing
- Intervention strategies including medication or surgery
- Where
- 4 sites in China
- Volunteers
- 500 people
- Sponsor
- DeltaHealth Hospital · Shanghai
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