Clinical trials: Defect, Congenital Heart
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
Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy, Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NTLA-2001 in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (ATTRv-PN) and Patients With Transthyretin Amyloidosis-Related Cardiomyopathy (ATTR-CM)
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NTLA-2001 in participants with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN) and…
- Conditions
- Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy, Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy, Wild-Type Transthyretin Cardiac Amyloidosis
- Trial name
- NCT04601051
- Testing
- NTLA-2001
- Where
- 4 sites in France, New Zealand and 2 more
- Volunteers
- 72 people
- Sponsor
- Intellia Therapeutics
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
Danon Disease
Gene Therapy for Male Patients With Danon Disease (DD) Using RP-A501; AAV9.LAMP2B
This is a non-randomized open-label Phase 1 study to evaluate the safety and toxicity of gene therapy using a recombinant adeno-associated virus serotype 9 (AAV9) containing the human lysosome-associated membrane protein 2…
- Trial name
- NCT03882437
- Testing
- RP-A501
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Rocket Pharmaceuticals Inc.
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
Turner Syndrome, Cardiovascular Diseases
Lymphedema, Low-grade Inflammation and the Vasculature in Turner Syndrome
100 women with karyotype verified TS, previously examined at 4 study visits during a 19-year period will be asked to participate in a 5th study visit. Healthy age-matched females will be included as controls in a ratio 2:1.
- Conditions
- Turner Syndrome, Cardiovascular Diseases, Lymphedema, Inflammation
- Trial name
- TSCOR_V (NCT06325618)
- Testing
- No intervention other than obtaining biopsies, Indocyanine green (ICG)
- Where
- Denmark
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
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
Pregnancy, Down Syndrome
Comparison of Aneuploidy Risk Evaluations
This is a prospective, multi-center observational study designed to compare the test results of the Verinata Health Prenatal Aneuploidy Test to results of conventional prenatal screening for fetal chromosome abnormalities in…
- Conditions
- Pregnancy, Down Syndrome, Edwards Syndrome, Patau Syndrome
- Trial name
- CARE (NCT01663350)
- Where
- 26 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Verinata Health, Inc.
Congenital Disorder, Heart Diseases
Supported Exercise Programme for Adults With Congenital Heart Disease
This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.
- Trial name
- SEACHange (NCT03262168)
- Testing
- Exercise Programme
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Golden Jubilee National Hospital
Fabry Disease, Fabry Disease, Cardiac Variant
Fabry Disease in High-risk Patients With Left Ventricular Hypertrophy: Prevalence and Implementation of a Clinical Score
This study aims to evaluate the prevalence of Fabry Disease (FD) among a cohort of high risk patients with left ventricular hypertrophy (LVH) presenting at the University Hospital Würzburg over the last 20 years.
- Conditions
- Fabry Disease, Fabry Disease, Cardiac Variant, Lysosomal Storage Diseases, HCM - Hypertrophic Cardiomyopathy
- Trial name
- FAPREV-HCM (NCT04943991)
- Testing
- blood sampling (alpha-Galactosidase & LysoGb3)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Wuerzburg University Hospital
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
Congenital Heart Defects
Effects of High-intensity Interval Training on Exercise Capacity in Patients With Grown-up Congenital Heart Disease
Patients with congenital heart disease have long been discouraged from participating in physical exercise which has led to impaired exercise capacity in this population.
- Trial name
- HIIT-GUCH (NCT02632253)
- Testing
- HIIT, MICE
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cardiac Amyloidosis
Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis
The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with [68Ga]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals…
- Trial name
- NCT05619302
- Testing
- [68Ga]CBP8 PET/MRI
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Dilated Cardiomyopathy (DCM)
Protein A Immunoadsorption in Dilated Cardiomyopathy (RPIA-DCM)
This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an…
- Trial name
- NCT06922851
- Testing
- Immunoadsorption
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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