Clinical trials: Cardiac Defect
Congenital Heart Disease (CHD)
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
This pilot study will look at whether putting back a child's own thymus tissue during heart surgery is safe and may help support the immune system in children with congenital heart disease (CHD).
- Trial name
- ATTT (NCT07799259)
- Testing
- Autologous Thymus Transplant
- Volunteers
- 10 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
This prospective observational cohort study evaluates a precision neuromuscular management strategy in pediatric patients undergoing minimally invasive cardiac surgery (MICS).
- Conditions
- Minimally Invasive Pediatric Cardiac Surgery, Pediatric Cardiac Surgery, Early Extubation Pathway, TOF-Guided Sugammadex Administration
- Trial name
- TOF (NCT07798011)
- Testing
- Sugammadex
- Where
- Vietnam
- Volunteers
- 80 people
- Sponsor
- Dr. Nguyen Thi Thu Hang
Congenital Heart Disease
HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD.
- Trial name
- HEARTPrep (NCT05129631)
- Testing
- HEARTPrep
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Nemours Children's Clinic
Heart Failure, Transplant; Failure, Heart
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist…
- Conditions
- Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
- Trial name
- NCT05610787
- Testing
- EXCOR Active Driving System for Pediatric VAD
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Berlin Heart, Inc
Creation of an Italian Network of Biobanks of Rare Diseases
ScATtEred Rare Disease Biobanks: a Model of Sample/Data Collection With susTainablE and Shared Criteria
Rare diseases (RDs) have been defined by the European Union (EU) as life-threatening or chronically debilitating conditions affecting less than 1 person in 2000.
- Trial name
- SATELLITES (NCT06782230)
- Where
- Italy
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- IRCCS Policlinico S. Donato
Coarctation of the Aorta, Coarctation of Aorta
Effects of Exercise in Patients With Repaired Coarctation of the Aorta
This interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta.
- Trial name
- KOREKT (NCT07771023)
- Testing
- Outpatient high-intensity interval training (HIIT), Home-based high-intensity interval training (HIIT)
- Where
- 2 sites in Slovenia
- Volunteers
- 45 people
- Sponsor
- University Medical Centre Ljubljana
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Hummingbird ICE Study
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of…
- Conditions
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Valve Disease, Heart, Atrial Septal Defect
- Trial name
- NCT07552272
- Testing
- ICE Image Guidance
- Volunteers
- 1,000 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Congenital Heart Disease, Health Behavior
Heart2Heart for Teens With CHD
The goal of this clinical trial is to learn if teens living with congenital heart disease like and will use Heart2Heart and if it affects how they think and feel about e-cigarettes.
- Trial name
- NCT07764510
- Testing
- Heart2Heart
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Kristen Fox
Congenital Heart Disease, Open Heart Surgery
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia.
- Conditions
- Congenital Heart Disease, Open Heart Surgery, Cardiopulmonary Bypass, Endocarditis Acute and Subacute
- Trial name
- LEAT (NCT07771491)
- Testing
- Hemoadsorption (Jafron HA-60/HA380)
- Volunteers
- 120 people
- Sponsor
- Norfaniza Zabidi
Congenital Heart Disease in Children
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU.
- Trial name
- CIVIK (NCT04040452)
- Testing
- Continuous ketorolac
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Phoenix Children's Hospital
Congenital Heart Disease (CHD)
Cord Clamping Among Neonates With Congenital Heart Disease
The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD).
- Trial name
- CORD-CHD (NCT06153459)
- Testing
- Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds, Umbilical Cord Milking
- Where
- 21 sites in United States, Canada
- Volunteers
- 500 people
- Sponsor
- Carl Backes, MD
Congenital Heart Disease, Bronchopneumonia
Research on Body Voice AI Recognition System for Children's Health Management
The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm…
- Conditions
- Congenital Heart Disease, Bronchopneumonia, Abdominal Disease
- Trial name
- NCT06542120
- Testing
- Heart Auscultation and Echocardiography, Chest Auscultation and Chest imaging examinations, Abdominal Auscultation and Abdominal imaging examinations
- Where
- 5 sites in China
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Heart Failure, Cardiogenic Shock
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1.
- Conditions
- Heart Failure, Cardiogenic Shock, Congenital Heart Disease, Cardiomyopathies
- Trial name
- TROLLEY (NCT06080074)
- Testing
- Cardiohelp device (VA-ECMO), Heparin, Bivalirudin
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Atrial Septal Defect, Ventricular Septal Defects
Comparison of Dynamic Compliance and Airway Resistance in Pressure-Controlled Versus Volume-Controlled Ventilation in Children Undergoing Corrective Heart Surgery
The goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children. The children in this study were born with a hole inside the heart.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defects, Pulmonary Hypertension, Intracardiac and Septal Defects
- Trial name
- NCT07754591
- Testing
- Pressure Controlled Ventilation, Volume Controlled Ventilation
- Where
- India
- Volunteers
- 72 people
- Sponsor
- Nilratan Sircar Medical College
Fontan Circulation
Muscle Function in Patients With Single-chamber Heart
Groundbreaking cardiac surgery has significantly improved survival rates for patients with single-chamber hearts. However, despite these life-saving interventions, the long-term prognosis remains concerning, with an increased…
- Trial name
- Muscle in TCPC (NCT07420660)
- Where
- Sweden
- Volunteers
- 34 people
- Sponsor
- Karolinska Institutet
Cardiac Diseases, Sickle Cell Disease
Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System
Cognizant of the prevalence of complicated non communicable diseases (NCD) and the attendant capacity problems faced by the health workers in primary care settings, we propose to adapt and pilot the Package of Essential…
- Conditions
- Cardiac Diseases, Sickle Cell Disease, Hypertension, Diabetes Mellitus
- Trial name
- PEN Plus (NCT07753681)
- Testing
- Supportive treatment
- Where
- Zambia
- Volunteers
- 2,084 people
- Sponsor
- Centre for Infectious Disease Research in Zambia
Heart Defect, Congenital
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring right ventricular outflow tract…
- Trial name
- Xplore2 (NCT03022708)
- Testing
- Xeltis Bioabsorbable Pulmonary Valved Conduit
- Where
- 10 sites in United States, Bulgaria and 2 more
- Volunteers
- 6 people
- Sponsor
- Xeltis
AKI, CHD - Congenital Heart Disease
NO During CPB in Neonates to Reduce Risk of AKI
Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality.
- Conditions
- AKI, CHD - Congenital Heart Disease, Surgery
- Trial name
- NCT04216927
- Testing
- Nitric Oxide, Oxygen
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Heart Disease
Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)
The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD).
- Trial name
- NCT05853705
- Testing
- Strong Hearts Exercise Program
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Duke University