Clinical trials: Heart Defects
Coagulopathy, Congenital Heart Disease
FFP Usage in Pediatric CV Surgery
When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg.
- Trial name
- NCT05819788
- Where
- Canada
- Volunteers
- 431 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Single-ventricle, Fontan Procedure
Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk.
- Conditions
- Single-ventricle, Fontan Procedure, Hemodynamic Instability, Arterial Stiffness
- Trial name
- NCT05011565
- Testing
- Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Univentricular Heart
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation.
- Trial name
- NCT05744934
- Testing
- LUX-Dx™
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
Atrial Septal Defect (ASD), Dexmedetomidine
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters.
- Conditions
- Atrial Septal Defect (ASD), Dexmedetomidine, Delirium - Postoperative, Stress Response
- Trial name
- NCT06631534
- Testing
- Dexmedetomidine
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Alexandria University
Univentricular Heart
Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients
The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.
- Trial name
- NCT05617534
- Where
- Ireland
- Volunteers
- 30 people
- Sponsor
- Children's Health Ireland
Respiratory Distress Syndrome in Premature Infant, Patent Ductus Arteriosus After Premature Birth
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
Respiratory distress syndrome (RDS) is among the most common complications of preterm birth, and typically becomes manifested soon after birth.
- Conditions
- Respiratory Distress Syndrome in Premature Infant, Patent Ductus Arteriosus After Premature Birth, Perinatal Morbidity
- Trial name
- NCT04359134
- Where
- 2 sites in Italy
- Volunteers
- 60 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Arrhythmogenic Right Ventricular Cardiomyopathy
Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)
This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2…
- Trial name
- RIDGE (NCT06311708)
- Where
- 21 sites in United States, France and 4 more
- Volunteers
- 200 people
- Sponsor
- Tenaya Therapeutics
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
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
Patent Ductus Arteriosus (PDA)
PREEMIE: Study for Treatment of PDA in Premature Infants
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants…
- Trial name
- PREEMIE (NCT06587282)
- Testing
- Bloom Micro Occluder System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- Merit Medical Systems, Inc.
Congenital Heart Disease (CHD), Artifical Intelligence
AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
This is a prospective, school-based, cluster-randomized controlled trial conducted in Qinghai Province, China. The study will evaluate whether artificial intelligence (AI) can help primary care physicians identify congenital…
- Conditions
- Congenital Heart Disease (CHD), Artifical Intelligence, Screening, Cardiac Auscultation
- Trial name
- NCT07830251
- Testing
- AI-Assisted Cardiac Auscultation
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Kun Sun
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
Bicuspid Aortic Valve
A Multicentre Retrospective Study on Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners.
- Trial name
- NCT05818722
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Heart Murmurs, Congenital Heart Disease
The Accuracy of an Artificially-intelligent Stethoscope
This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant…
- Conditions
- Heart Murmurs, Congenital Heart Disease, Structural Heart Disease
- Trial name
- NCT00564122
- Testing
- Artificially-Intelligent Stethoscope, Physical Examination
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Akron Children's Hospital
Congenital Heart Disease, Mother Child Interaction
Creative Music Therapy in Newborns With Congenital Heart Disease
In the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads…
- Trial name
- BOND (NCT05702203)
- Testing
- Creative Music Therapy
- Where
- Switzerland
- Volunteers
- 164 people
- Sponsor
- University Children's Hospital, Zurich
Persistent Ductus Arteriosus
Betamethasone and Closure of Ductus Arteriosus
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality…
- Trial name
- CELESTE (NCT05987202)
- Testing
- DA closure in a population of premature infants
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Ostium Secundum Atrial Septal Defect
Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment
The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment…
- Trial name
- NCT02601768
- Testing
- Transcatheter closure of ASD II
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland
Single-ventricle, Congenital Heart Disease
Fontan Imaging Biomarkers (FIB) Study
The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.
- Trial name
- FIB (NCT03119090)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Boston Children's Hospital
Aortic Coarctation, Arterial Stiffness
Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment
Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long term cardiovascular (CV)…
- Conditions
- Aortic Coarctation, Arterial Stiffness, PULSE WAVE VELOCITY, Functional Magnetic Resonance Imaging
- Trial name
- LOVE-COARCT (NCT03262753)
- Testing
- Surgery, Balloon dilation, Stent
- Where
- Portugal
- Volunteers
- 90 people
- Sponsor
- Centro Hospitalar de Lisboa Central
Congenital Heart Defects, Hypoplastic Left Heart Syndrome
Cerebral Perfusion During Neonatal Cardiac Surgery
Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA).
- Conditions
- Congenital Heart Defects, Hypoplastic Left Heart Syndrome, Aortic Coarctation
- Trial name
- NCT01032876
- Testing
- Deep Hypothermic Circulatory Arrest, Antegrade Cerebral Perfusion
- Where
- Netherlands
- Volunteers
- 37 people
- Sponsor
- UMC Utrecht
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