Clinical trials: Cardiac Defect
Serious Games, Transition-age Youth
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health independently.
- Conditions
- Serious Games, Transition-age Youth, Transition to Adult Care, Congenital Heart Defect
- Trial name
- NCT07042334
- Testing
- Serious game for transition readiness
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- University of Utah
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Intellectual Disability, Rubinstein-Taybi Syndrome
Functional Tests to Resolve Unsolved Rare Diseases. Rares.
Rares diseases are a heterogeneous group of conditions which need important tools for diagnosis. The use of high-throughput sequencing is able to diagnose half of the patients.
- Conditions
- Intellectual Disability, Rubinstein-Taybi Syndrome, Cystic Fibrosis, Congenital Heart Defect
- Trial name
- RID (NCT05696912)
- Testing
- Ex-vivo approach concerning 25 patients, In-vitro approach concerning 25 patients
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Bordeaux
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
General Anesthesia, Dexmedetomidine
General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients
The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous…
- Conditions
- General Anesthesia, Dexmedetomidine, Ketamine, Local Infiltration
- Trial name
- NCT06431178
- Testing
- General Anesthesia, Local anesthesia
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Tanta University
Atrial Septal Defect (ASD)
A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment.
- Trial name
- PANNA-ASD (NCT07054541)
- Testing
- Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention
- Where
- China
- Volunteers
- 666 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
Pediatric ALL, Cardiac Defect
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings.
- Trial name
- PACH (NCT06529575)
- Where
- 3 sites in United States
- Volunteers
- 650 people
- Sponsor
- University of Pennsylvania
Conduction Defect
Subcostal Temporary Extracardiac Pacing II Study
Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for…
- Trial name
- STEP II (NCT04374929)
- Testing
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
- Where
- 2 sites in New Zealand, Paraguay
- Volunteers
- 7 people
- Sponsor
- AtaCor Medical, Inc.
Cardiovascular Diseases, Heart Diseases
Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease
To identify genes involved in the pathogenesis of congenital heart disease, including atrial septal defects (ASDs), paramembranous ventricular septal defects (VSDs), and atrioventricular canal defects (AVCDs).
- Conditions
- Cardiovascular Diseases, Heart Diseases, Defect, Congenital Heart, Heart Septal Defects, Atrial
- Trial name
- NCT00005322
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Congenital Heart Defect
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the…
- Trial name
- MRWIREPMCF (NCT02493634)
- Testing
- pressure gradient measurement, MRWire
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Nano4Imaging GmbH
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
BIO|MASTER.CSP Study
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP).
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia
- Trial name
- NCT06620237
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 14 sites in Australia, Belgium and 3 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Septal Defect, Papillary Muscle Rupture
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on…
- Conditions
- Ventricular Septal Defect, Papillary Muscle Rupture, Cardiac Rupture, Pseudoaneurysm
- Trial name
- CAUTION 2 (NCT06676345)
- Testing
- Surgical treatment, Percutaneous treatment
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- Maastricht University Medical Center
Cardiac Transplant, Patent Ductus Arterious
The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis…
- Conditions
- Cardiac Transplant, Patent Ductus Arterious, Atrial Septal Defect, Bidirectional Cavopulmonary Anastomosis
- Trial name
- NCT00480740
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Children's National Research Institute
Heart Septal Defects, Ventricular, Atrioventricular Septal Defect
Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow
Infants with congenital heart disease and increased pulmonary blood flow have altered carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment will attenuate these alterations and improve…
- Trial name
- L-carn (NCT01825369)
- Testing
- IV L-carnitine
- Where
- United States
- Sponsor
- University of California, San Francisco
Atrial Septal Defect
Holter and ECG Changes After Transcatheter Closure Of ASD In Children
Atrial septal defects (ASD) account for 10% of all congenital heart defects [1]. Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the…
- Trial name
- NCT05540769
- Testing
- catheter guided ASD closure
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Sohag University
Pediatric Pulmonary Hypertension
Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt. analyze the efficacy and side effects.
- Trial name
- NCT03431649
- Testing
- Beraprost Sodium, Sildenafil Citrate
- Where
- Indonesia
- Volunteers
- 40 people
- Sponsor
- Dr. Soetomo General Hospital
Congenital Heart Defect, Congenital Heart Disease
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block.
- Conditions
- Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local, Opioid Use
- Trial name
- NCT03611374
- Testing
- Bilateral Erector Spinae Plane Block (ESPB)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Stanford University
Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact…
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation, Familial Hypercholesterolemia - Heterozygous
- Trial name
- ACCURATE (NCT05218005)
- Testing
- Research-based genetic test for Familial Hypercholesterolemia
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- University of British Columbia
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