Clinical trials: Cardiac Defect
Coagulation Defect; Bleeding
Quantra QPlus Sample Type Comparison
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
- Trial name
- NCT05290675
- Testing
- Quantra QPlus System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HemoSonics LLC
Congenital Heart Defect, Patent Ductus Arteriosus
Effect of PDA Closure on the Left Ventricular Remodeling
failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal…
- Trial name
- NCT04964531
- Testing
- speckle tracking echocardiography
- Volunteers
- 48 people
- Sponsor
- Ahmed Mohamed Moheb El-Din
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Congenital Heart Defect, Dental Caries in Children
Oral Health Intervention Program for Children With Congenital Heart Defects
Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children.
- Conditions
- Congenital Heart Defect, Dental Caries in Children, Dental Erosion, Dental Plaque
- Trial name
- NCT03311438
- Testing
- Oral health intervention program
- Volunteers
- 75 people
- Sponsor
- University of Bergen
Left Ventricular Dysfunction, Cardiac Conduction Defect
Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site.
- Conditions
- Left Ventricular Dysfunction, Cardiac Conduction Defect, Heart Failure, Sick Sinus Syndrome
- Trial name
- NCT01609738
- Testing
- Left ventricular septum pacing lead
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Maastricht University Medical Center
ASD - Atrial Septal Defect
A Multicenter Randomized Controlled Trial of Echocardiography-Guided Atrial Septal Defect Closure Performed in a Mobile Surgical Unit
Cardiovascular disease remains a major threat to global health, and structural heart disease which encompassing congenital heart defects, valvular disease, and cardiomyopathies constitutes a substantial proportion of its burden.
- Trial name
- NCT07273227
- Testing
- Mobile Surgical Vehicle Echocardiography-guided ASD closure Group, Conventional Operating Room Echocardiography-guided ASD closure Group
- Where
- China
- Volunteers
- 300 people
- Sponsor
- China National Center for Cardiovascular Diseases
Cardiac Disease, Respiratory Disease
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject.
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases
- Trial name
- BRIDGE (NCT05319236)
- Testing
- Gabi System
- Where
- 4 sites in United States, Belgium
- Volunteers
- 101 people
- Sponsor
- Gabi SmartCare
Heterotaxy Syndrome, Congenital Heart Defects
Molecular Genetics of Heterotaxy and Related Congenital Heart Defects
The goal of this study is to obtain specimens and data from individuals and their families with heterotaxy and related congenital heart defects in order to clarify the molecular genetics of this disorder.
- Trial name
- NCT02432079
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Indiana University
Cardiovascular Diseases, Heart Diseases
Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease
To identify genes involved in the pathogenesis of three types of congenital heart disease, atrial septal defects, paramembranous ventricular septal defects, and atrioventricular canal defects.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Heart Septal Defects, Ventricular
- Trial name
- NCT00005546
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect
Trevisio Post-Approval Study
A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices.
- Conditions
- PFO - Patent Foramen Ovale, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PIVSD - Post Infarct Muscular Ventricular Septal Defect
- Trial name
- TrevisioPAS (NCT04433520)
- Testing
- Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer PFO Occluder, ASO or Amplatzer Cribriform Occluder, Amplatzer™ Trevisio™ Intravascular Delivery System using Amplatzer Muscular VSD Occluder or Amplatzer Post-Infarct Muscular VSD Occluder
- Where
- 22 sites in France, Germany and 5 more
- Volunteers
- 254 people
- Sponsor
- Abbott Medical Devices
DiGeorge Syndrome, Shprintzen Syndrome
Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome
OBJECTIVES: I. Determine the pattern of immunologic reconstitution in patients with T-cell compromise due to DiGeorge syndrome or velocardiofacial syndrome. II.
- Conditions
- DiGeorge Syndrome, Shprintzen Syndrome, Chromosome Abnormalities, Abnormalities, Multiple
- Trial name
- NCT00005102
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- National Center for Research Resources (NCRR)
Coronary Artery Disease
Use of Stress-CMR Using Regadenoson and GE-267 in Adult Patients with Known or Suspected Coronary Artery Disease
Stress cardiac MRI is crucial for diagnosing coronary artery disease in adults. Currently, it is mainly performed with vasodilators in specialized centers.
- Trial name
- NCT06246188
- Testing
- Cardiac MRI using Regadenoson and GE-267
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- German Heart Institute
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
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
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
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
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
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Ventricular Dysfunction, Pericardial Effusion
Focused Cardiac Ultrasound
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
- Conditions
- Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect
- Trial name
- NCT03887286
- Testing
- Philips EPIQ 7 ultrasound machine, Philips Lumify Broadband sector array transducer
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- University of Miami