Congenital heart disease

This study tests whether Empagliflozin (Jardiance), a drug used for diabetes and heart failure, can help adults born with heart defects who now have a weakened heart. Forty participants will receive either the drug or a placebo for one year. Researchers will measure changes in he…

This international registry study looks at a small device called a transcatheter pulmonary flow restrictor, which doctors implant in the lung arteries of young children with congenital or acquired heart disease. The goal is to see whether the device safely and effectively control…

This study follows 300 people with blocked leg arteries who received a treatment using a balloon coated with paclitaxel and vitamin E. The goal is to see if the balloon keeps the artery open and prevents the need for repeat procedures over one year. Participants are adults with m…

This study is testing a new driving system for the EXCOR Pediatric heart pump, which helps children with severe heart failure while they wait for a heart transplant. About 40 children will take part to see if the new driver works safely and effectively. The goal is to keep patien…

This study tests whether high-intensity interval training (HIIT) can improve cardiovascular health in adults who had surgery to repair coarctation of the aorta, a narrowing of the main artery. Participants are randomly assigned to do HIIT at home, HIIT in a supervised clinic, or …

This trial is testing a new type of heart valve made from a material that the body absorbs over time. It is designed for children and young adults who need surgery to fix a congenital heart defect affecting the passage from the heart to the lungs. The valve is implanted during su…

This trial tests whether a personalized training program called 'Kleuter Extra' can improve executive functioning—skills like attention, self-control, and planning—in preschoolers aged 4 to 6 who have severe congenital heart disease. Many children with this condition face thinkin…

This study tests a special heart valve for children aged 1.5 to 16 years with congenital heart disease who need a pulmonary valve replacement. The valve can be expanded after implant to match the child's growth, potentially avoiding multiple surgeries. Researchers will check safe…

This pilot study tests whether actively managing blood pressure during heart surgery in newborns can reduce dangerous low blood pressure episodes. About 130 newborns will be randomly assigned to either standard care or a new approach using a special monitor to keep blood pressure…

This trial investigates whether pulsed field ablation (PFA) can safely isolate the pulmonary veins in adults with congenital heart disease who experience atrial tachycardia. Participants will undergo PFA during a standard ablation procedure. The study measures how well the veins …

This study looks at children with congenital heart disease who take the blood thinner rivaroxaban after a Fontan procedure. The goal is to see how often serious or minor bleeding happens. Researchers will collect data from regular doctor visits for up to 2 years. No extra tests o…

This study tests a behavioral program called Individualized Developmental Care (NIDCAP) for newborns with complex congenital heart disease. The program aims to reduce stress from the hospital environment by supporting parent involvement, creating a soothing setting, and adjusting…

This study looks at how well the Harmony Transcatheter Pulmonary Valve (TPV) works when used by doctors in everyday practice. It involves 174 people with congenital heart disease who need a new pulmonary valve. The main goal is to see if the valve works properly without needing a…

This early-phase trial tests whether giving stem cells (from a donor) during heart-lung bypass surgery is safe for infants under 6 months with certain congenital heart defects. Seventeen infants will receive the cells while undergoing heart repair. The main goal is to check for s…

This study tests a new device called the Occlutech Flex II PFO Occluder, which is used to close a small hole in the heart (PFO) that can cause strokes. The trial involves 450 people who have had a stroke with no clear cause and a PFO. Researchers want to see if the new device wor…

This study tests a small device called the BLOOM Micro-Occluder to close a common heart hole (PDA) in premature babies. About 55 babies weighing between 600 and 2500 grams will be enrolled. The goal is to see if the device is safe and works well over 6 months.

This study tests whether propranolol, a drug often used for high blood pressure, can safely treat chylothorax—a buildup of lymphatic fluid—in children after open heart surgery. About 50 children aged 7 days to 18 years with congenital heart disease will receive either propranolol…

This study looks at whether actively treating a heart condition called patent ductus arteriosus (PDA) in premature babies is better than simply monitoring it. About 482 infants born between 22 and 28 weeks of pregnancy will be followed to see which approach reduces the risk of de…

This study is testing a less invasive procedure called TAVR to replace the aortic valve in 150 people who have a bicuspid aortic valve (a valve with two flaps instead of three) and severe narrowing. The goal is to see if it is safe and works well for people who are at low risk fo…

This study looks at a procedure done before birth to help babies with a severe heart defect called hypoplastic left heart syndrome (HLHS). The goal is to improve blood flow through the heart so that the baby may have a better chance at a two-sided heart repair after birth. The st…

This study tests a new device called the PULSTA valve, which is placed inside the heart through a tube in a blood vessel, avoiding open-heart surgery. It is for 58 people with a leaky or narrowed pulmonary valve, often due to a birth defect. The goal is to see if the valve is saf…

This study tests a new way to manage blood flow and oxygen in children right after heart surgery. The goal is to help their bodies use oxygen better during the critical first 8 hours, which may prevent dangerous drops in blood pressure or heart function. About 300 children weighi…

This study looks at a device called the AMPLATZER PFO Occluder, which is implanted to close a hole in the heart (PFO) in people who have had a stroke. Over 1,200 participants are being followed for up to 5 years to see if the device prevents another stroke and is safe. The goal i…

This study is tracking 200 people with blocked leg arteries who are receiving a special balloon coated with the drug paclitaxel (GENOSS PCB). The balloon is inflated inside the artery to open it and release the drug, which helps prevent the artery from narrowing again. Researcher…

This study is testing a new device called the GORE PV1 to replace the pulmonary valve and rebuild the right ventricular outflow tract in people with congenital heart defects. The device is designed to improve blood flow from the heart to the lungs. The study includes 15 participa…

This study is testing a new heart valve, called the SAPIEN 3, in 150 people with congenital heart defects whose existing heart valves are not working properly. The valve is placed using a thin tube (catheter) through a blood vessel, avoiding open-heart surgery. The goal is to see…

This study follows 50 people who have a hole in the wall between their heart's lower chambers (a perimembranous VSD). They received a special device to close the hole without open-heart surgery. Researchers are checking if the device stays in place and closes the hole properly, a…

This study compares two procedures used to increase blood flow to the lungs in newborns with congenital heart disease: a surgical shunt or a stent placed via catheter. About 300 babies will be randomly assigned to one method and followed for their first year. The goal is to see w…

This study tests whether giving the steroid hydrocortisone early, right when shock is diagnosed, helps very small preterm babies (under 1500 grams) recover faster. Researchers will compare babies who get standard shock treatment plus hydrocortisone to those who get standard treat…

This study is checking how well a device called the GORE® CARDIOFORM Septal Occluder works and how safe it is for people who have had a stroke caused by a hole in the heart (PFO). Researchers will follow 300 patients in Japan for 12 months after the device is implanted. The goal …

This study looks at a new device to fix leaky pulmonary valves in people born with heart defects. About 150 people will get the Edwards SAPIEN 3 valve placed inside a special stent. The goal is to see if the valve works well and stays in place without major problems.

This study tests whether adding nitric oxide gas to the heart-lung machine during surgery can reduce damage to the brain and kidneys in infants under 1 year old with congenital heart disease. Researchers will measure specific proteins in the blood before and after surgery and mon…

This study monitors 70 infants who receive the Amplatzer Piccolo Occluder to close a hole in the heart called patent ductus arteriosus (PDA). The device is placed through a blood vessel, avoiding open-heart surgery. Researchers track complications and how well the hole closes ove…

This study tests a new device (Alterra Prestent) used with a replacement heart valve (SAPIEN 3) to fix a leaky pulmonary valve in people born with heart defects. About 86 participants with moderate or severe leakage will get the device through a tube in a blood vessel, avoiding o…

This study is testing a new type of heart valve called the Harmony TPV, which is placed using a thin tube (catheter) instead of open-heart surgery. It is for people with congenital heart disease who have a leaky pulmonary valve. The study will check if the valve works well and is…

This study compares two ways to replace a narrowed heart valve in people with a bicuspid aortic valve (a common birth defect). One method is transcatheter aortic valve replacement (TAVR), a less invasive procedure using a tube inserted through a blood vessel. The other is traditi…

This study tests whether a new MRI technique, called 5D flow, can measure blood flow and pressure in the heart as accurately as the standard invasive procedure, right-left heart catheterization. People with congenital heart conditions who already need a catheterization will also …

This trial is developing an artificial intelligence system that reads electrocardiograms (ECGs) to detect congenital heart disease in children. Researchers are collecting ECG data from thousands of children, including those with common and rare heart defects, to train a deep-lear…

This study tests a smartphone app called ausculto™ that records and analyzes heart sounds to detect congenital heart disease. Researchers will record heart sounds from 220 people aged 6 and older who have had recent echocardiograms. The goal is to see if the app can accurately te…

Researchers test whether flecainide, an antiarrhythmic drug, can prevent atrial arrhythmias in adults who have a patent foramen ovale (PFO) closed after a cryptogenic stroke. Participants receive flecainide or standard care for 3 to 6 months. An insertable cardiac monitor records…

Researchers are testing whether a suture-based closure device helps patients recover faster after heart procedures that use a large tube placed in the femoral vein. The trial enrolls adults undergoing procedures such as atrial fibrillation ablation, leadless pacemaker insertion, …

This trial compares two ultrasound-guided nerve blocks—erector spinae plane block and modified pectoral fascial plane block—for pain control in children undergoing congenital heart surgery. Forty children will be randomly assigned to receive one of the blocks before their incisio…

This study tests whether peer health coaching—support from someone with similar experiences—can help young adults (ages 18-26) with congenital heart disease better manage their condition. Participants receive coaching via secure phone calls and texts over 6 months. The goal is to…

This study tests whether a probiotic supplement called Neuralli® MP can help adults aged 18 to 50 who have autistic traits. Participants take two capsules daily and set their own personal goals to track progress. The trial is small and open-label, meaning everyone knows they are …

This study aimed to see if freezing certain nerves during minimally invasive heart surgery could lower pain afterward. It planned to enroll adults having mitral valve or atrial septal defect repair. However, the trial was withdrawn before any participants were enrolled, so no dat…

This study tests whether a web-based decision aid app can reduce stress and improve decision-making for parents whose baby is diagnosed with a life-threatening congenital heart defect. 135 parents are randomly assigned to use the app alone or with an added values clarification ex…

This study tests whether a type of brain stimulation called rTMS can reduce depression in people with autism. Twenty-four participants aged 13 to 26 will receive either real or sham (fake) stimulation to see if it helps. The goal is to find a new way to treat depression that hasn…

This study tests a gamified app called MITA designed to improve language and thinking skills in children with autism aged 2 to 5. Sixty children will be randomly assigned to either use the app alongside their usual therapy or continue with standard care alone. The goal is to see …

This study aimed to test a support toolkit for families of children with congenital heart disease. The toolkit included an iPad with a hospital app, educational materials, and help with transportation and childcare. Only 5 families were planned to participate, but the study was w…

Researchers are running an international registry to follow adults who had an ischemic stroke or transient ischemic attack and also have a patent foramen ovale, a small opening between the upper chambers of the heart. The registry collects real-world information on how these pati…

This study is testing a new video game designed to help teenagers with congenital heart disease learn how to manage their own healthcare. The game teaches skills like talking to doctors, understanding medical information, and keeping track of appointments and medications. About 1…

Researchers in Uzbekistan are studying common respiratory and heart conditions in children from birth to age 15. They will analyze medical records and examine blood samples to understand immune and antioxidant function in affected children. The goal is to develop and test improve…

This trial tests a website called Heart2Heart, created for teens living with congenital heart disease. The site provides health information and interactive tools to help them stay healthy. Researchers want to see if teens will use and enjoy the site, and whether it changes their …

This study follows individuals with autism who carry a PTEN gene mutation, along with comparison groups, to track changes in thinking, language, and behavior over time. Researchers will also collect blood samples and medical data to build a large database for future studies. The …

This study looks at children diagnosed with a ventricular septal defect (a hole in the heart) to understand if and when the hole might close without treatment. Researchers will follow children from birth to age 14 and use echocardiography to track the defect. The goal is to build…

This study explores whether artificial intelligence can predict which children with a type of heart hole (perimembranous ventricular septal defect) will later develop complications like valve problems or blockages. Researchers will analyze past echocardiogram reports and medical …

This study was designed to compare electrical and mechanical activation of the right ventricle in adults who had surgery for Tetralogy of Fallot, a congenital heart condition. Researchers planned to use 3D mapping and imaging to see if electrical signals match the heart's physica…

This study is looking at whether an artificial intelligence tool can help doctors decide which heart surgery patients might benefit from a drug called ulinastatin. Ulinastatin is used to reduce inflammation after surgery, but it doesn't work for everyone. Researchers will analyze…

This study is testing a mobile app called CHAMP that lets parents of children with complex congenital heart disease enter health data and upload photos or videos from home. The goal is to see if the app helps doctors monitor the child's condition remotely and improve communicatio…

This study looks at 224 adults who had surgery as children for a heart defect called tetralogy of Fallot. Researchers are using MRI scans and blood tests to measure scarring in the heart muscle. They want to see if this scarring is linked to serious heart problems like arrhythmia…

This study was designed to see if a test using acetylcholine could predict whether people with congenital heart disease and high blood pressure in the lungs would develop worsening high blood pressure after surgery to close a heart shunt. The test would have measured how well the…

This study at Boston Children's Hospital will test whether measuring thousands of proteins in a few drops of blood can predict which children with congenital heart disease will have serious complications after heart surgery. Researchers will collect blood samples from 60 children…

This study is looking for the genetic causes of bicuspid aortic valve disease, a common heart condition where the aortic valve has two flaps instead of three. Researchers will analyze DNA from 11,000 participants, including patients and their relatives, to find gene changes linke…

This study planned to check if blood tests taken during and after pregnancy could help predict future heart problems in women with adult congenital heart disease. The goal was to see if changes in these tests over time gave better warnings than a single test. However, the study w…

This study follows 526 preterm infants born before 30 weeks who have a condition called patent ductus arteriosus (PDA), where a fetal blood vessel stays open too long. Researchers collect heart ultrasound, blood, and urine tests over the first month to predict which babies will c…

This study follows 30 infants with congenital heart disease who need heart surgery. Researchers will use blood tests, EEG brain wave monitoring, and MRI scans to look for signs of brain injury. The goal is to find better ways to detect brain damage early and identify which childr…

This study aims to uncover the genetic roots of aortic aneurysms and valve disease by analyzing tissue and blood samples from 3,000 participants. Researchers will look for new disease-causing genes and factors that affect disease severity. The goal is to build a biorepository to …

This study tests a digital tool called AsthmaOptimiser that helps doctors assess asthma control and find ways to improve treatment during a single visit. About 746 adults with asthma who have had recent flare-ups will take part. The goal is to see if the tool can identify better …

This study is collecting DNA and health information from 32,000 people with congenital heart defects. Researchers hope to find genetic causes and understand why outcomes vary. No treatment is being tested—this is a research study to gather knowledge.

This study is looking for new genes that may cause certain types of congenital heart disease, specifically transposition of the great arteries. Researchers will collect DNA from up to 300 children with these heart defects and their parents to find genetic changes. The goal is to …

This study looks at 237 children born with hypoplastic left heart syndrome (HLHS), a serious heart defect. Researchers compare how well the heart works at age 11 in children who received one of two different shunts during their first surgery. The goal is to understand which shunt…