Clinical trials: Heart Defects
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Patent Ductus Arteriosus After Premature Birth
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, < 27+0 weeks).
- Trial name
- NCT05340582
- Testing
- Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection
- Where
- 9 sites in Australia, Canada and 2 more
- Volunteers
- 310 people
- Sponsor
- Mount Sinai Hospital, Canada
Congenital Heart Disease
Assessing and Promoting Resilience in Patients With Adult Congenital Heart Disease
The purpose of this study is to evaluate the feasibility and preliminary efficacy of the Promoting Resilience in Stress Management (PRISM) intervention in patients with adult congenital heart disease.
- Trial name
- PRISMACHD (NCT04738474)
- Testing
- Promoting Resilience in Stress Management (PRISM), Usual Care
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- University of Washington
Neutropenia
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are…
- Trial name
- NCT06056297
- Testing
- Mavorixafor
- Where
- 114 sites in United States, Argentina and 23 more
- Volunteers
- 176 people
- Sponsor
- X4 Pharmaceuticals
Congenital Disorders
Optimal Timing for Repair of Right-to-Left Shunt Lesions
The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects. The secondary aim being define the criteria for failing medical therapy.
- Trial name
- NCT00268099
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Children's Healthcare of Atlanta
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Migraine, Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
- Conditions
- Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
- Trial name
- RELIEF (NCT04100135)
- Testing
- Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel)
- Where
- 15 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Heart Disease, Congenital, Single Ventricle
Single Ventricle Outcome
The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.
- Conditions
- Heart Disease, Congenital, Single Ventricle, Hypoplastic Left Heart Syndrome
- Trial name
- NCT00308217
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Hypoplastic Left Heart Syndrome, Aortic Coarctation
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
Cardiovascular Response to Maternal Hyperoxygenation in Fetal Congenital Heart Disease
- Conditions
- Hypoplastic Left Heart Syndrome, Aortic Coarctation, Atrial Septal Aneurysm
- Trial name
- NCT03147014
- Testing
- Maternal hyperoxygenation
- Where
- China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Beijing Anzhen Hospital
Cardiac Tumor
A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma
This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after…
- Trial name
- NCT07132593
- Testing
- ventricular reconstruction
- Where
- China
- Volunteers
- 17 people
- Sponsor
- China National Center for Cardiovascular Diseases
Congenital Heart Disease
Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood
The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases.
- Trial name
- NCT03917706
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 118 people
- Sponsor
- Pierre Wauthy
Postoperative Hemorrhage
Tranexamic Acid in Cyanotic Heart Defects
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies
- Trial name
- NCT03244423
- Testing
- Normal saline at induction, Normal saline infusion, Intravenous tranexamic acid
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Assiut University
Tetralogy of Fallot
Pediatric REPlAcement of the PulmonaRy ValvE in Tetralogy of Fallot -
Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect with the vast majority of survivors of corrective surgery left with some degree of right ventricular (RV) volume overload due to pulmonary…
- Trial name
- TOFandPVR (NCT03634072)
- Testing
- PVR
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Children's Hospital of Philadelphia
RAS Mutation, Neurofibromatosis 1
RASopathy Biorepository
The RASopathies are a group of developmental disorders caused by genetic changes in the genes that compose the Ras/mitogen activated protein kinase (MAPK) pathway. New RASopathies are being diagnosed frequently.
- Conditions
- RAS Mutation, Neurofibromatosis 1, Noonan Syndrome, Noonan Syndrome With Multiple Lentigines
- Trial name
- NCT04395495
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Heart Disease
ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery
The ventilator modality of automatic tube compensation (ATC) can provide variable pressure supports during the weaning process to overcome any change in the resistance of the breathing circuit, endotracheal tube, and airways.
- Trial name
- NCT05344872
- Testing
- Weaning from mechanical ventilation
- Where
- Egypt
- Volunteers
- 34 people
- Sponsor
- University of Alexandria
Heart Defects, Congenital
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and…
- Trial name
- ACHD-CARE (NCT01881893)
- Testing
- ACHD-CARE Program
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- University Health Network, Toronto
Cardiovascular Diseases, Heart Diseases
Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery
This study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Defects, Congenital
- Trial name
- NCT00201214
- Testing
- Citrulline
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Vanderbilt University
Patent Ductus Arteriosus
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.
- Trial name
- NCT00440804
- Testing
- ibuprofen l-lysine iv solution (NeoProfen (R) )
- Sponsor
- Farmacon
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
CHD - Congenital Heart Disease
Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program
Standard cardiovascular rehabilitation is performed in a medical care and rehabilitation centre. However, it may not be adapted to the patient's profile and there are few medical care and rehabilitation centres specialized in…
- Trial name
- Muscletoncoeur (NCT07115589)
- Testing
- Muscle Your Heart home-based program
- Where
- France
- Volunteers
- 21 people
- Sponsor
- University Hospital, Bordeaux
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