Congenital heart malformation

This study tests whether injecting botulinum toxin (Botox) into fat pads around the heart's veins during cardiac surgery can prevent atrial fibrillation (AFib), a common and serious complication. About 220 adults undergoing heart surgery will receive either Botox or a placebo inj…

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 study tests a special tube called a stent graft to repair damage in the upper part of the main artery from the heart (the ascending aorta). It is for people with bulges (aneurysms), tears (dissections), or other lesions that usually need open-heart surgery. The goal is to se…

This study planned to test a new surgical approach for people with pulmonary vein stenosis, a condition where the veins carrying blood from the lungs to the heart become narrowed. The procedure involved transplanting a donor's left atrium and pulmonary veins, followed by lifelong…

This Phase 3 study tests a weekly injection called retatrutide in about 1,946 people with severe obesity (BMI ≥35) and established heart disease. The goal is to see if it helps with weight loss and improves heart-related health measures over 113 weeks compared to a placebo. Parti…

This study tests whether a weekly injection of CagriSema (a combination of two drugs) can reduce the risk of heart attacks, strokes, and other heart-related events in people with established cardiovascular disease. About 7,100 participants will receive either CagriSema or a place…

This study compares two ways to place stents in the left main coronary artery when there is a blockage at the opening of a branch. One method places a stent only in the blocked branch, while the other extends a stent from the main artery into the branch. Researchers will track 10…

This study is testing a less invasive procedure using stent-grafts to treat various types of aortic disease, including aneurysms and dissections. It involves 170 participants who are considered too high-risk for traditional open surgery. The goal is to see if this endovascular ap…

This phase 3 trial tests whether a monthly injection of pelacarsen can reduce major heart problems like heart attacks and strokes in people with high levels of Lp(a), a genetic risk factor. Over 8,000 participants with existing heart disease are being followed for several years. …

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 large study is testing whether a lower blood pressure target can reduce major heart problems like heart attacks, strokes, and heart failure in people with type 2 diabetes. About 9,500 participants with high blood pressure and high cardiovascular risk are being randomly assig…

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 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 phase 3 trial tests whether upadacitinib (Rinvoq) can help people with Takayasu arteritis, a rare disease that inflames large arteries. About 56 adults who have had a recent relapse despite steroids will receive either upadacitinib or a placebo, along with a steroid taper. T…

This study compares two solutions, Custodiol and Custodiol-N, used to protect the heart during surgery for children with congenital heart defects. About 100 children will receive one of the two solutions while on a heart-lung machine. The goal is to see which one is safer and bet…

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 tests whether giving patients capsules containing gut bacteria (called Probacine) before and after heart surgery can reduce gut injury and organ failure. Researchers will enroll 500 adults undergoing cardiovascular surgery. The goal is to see if changing the gut microb…

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 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 explores whether a simple, non-invasive leg movement test can measure blood vessel health in older adults. Researchers will use ultrasound to track blood flow changes after a passive leg movement, comparing young healthy people and older patients undergoing heart tests…

This large study tested whether taking daily vitamin D3 and omega-3 (fish oil) supplements can lower the risk of developing cancer, heart disease, or stroke. Over 25,000 healthy older adults (men 50+, women 55+) took the supplements or placebos for about 5 years. The goal is to s…

This study tests a nurse-led education program designed to help women in cardiac rehab address sexual concerns after a heart event. Sixty-six women will be randomly assigned to either the program or usual care. The goal is to see if the program improves sexual function, mood, and…

This study tests a two-part virtual program for teens aged 13-18 with Fontan physiology, a type of single-ventricle heart disease. The first part is a small-group wellness education session each week for 5 weeks, led by a psychologist. The second part is a personalized home exerc…

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 combining standard monitoring tools with new light-based sensors can better detect a dangerous narrowing of the aorta in newborns. Infants under one month old with suspected aortic arch obstruction will be monitored using resonance Raman spectroscopy, pul…

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 tracks 120 adults with heart disease and at least two other long-term illnesses to see how often dangerous drug interactions happen. Researchers check medications, including over-the-counter and herbal products, and follow participants for a year. The goal is to unders…

This study collects tissue samples from 1,000 people having heart valve surgery to find genetic causes of calcific aortic valve disease. Researchers will compare normal and diseased tissue to understand why the disease develops. Participants must be at least 20 years old and have…

This study collects data from 1,200 patients undergoing surgery for aortic dissection, a life-threatening tear in the heart's main artery. Researchers will track death rates, strokes, and other complications to identify the safest surgical strategies. The goal is to improve outco…

This study follows 900 patients with a life-threatening tear in the aorta (type A aortic dissection) to compare outcomes between different surgical techniques. Researchers will track deaths, strokes, heart failure, and other complications within 30 days after surgery. The goal is…

This study tracks over 1,700 heart patients who had hip or knee replacement surgery. Researchers want to see how often bleeding or blood clots happen in the months after surgery. The goal is to find better ways to prevent these complications.

This study measures certain substances in the blood (biomarkers) of infants with a rare heart defect called single-ventricle. The goal is to understand how these biomarkers relate to lung blood flow before and after a specific heart surgery (superior cavo-pulmonary anastomosis). …

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 will observe 200,000 Chinese adults with heart disease to see how their heart and lung function changes over 5 years. Participants will take a special exercise test to measure their fitness. Researchers hope to find better ways to predict future heart problems like hea…

This study follows 770 people who had aortic aneurysm repair using branched stent grafts. Researchers will check kidney function and other organ health over two years to see how different stent designs affect outcomes. The goal is to learn which approaches work best for preservin…

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 follows 2000 people with dilated cardiomyopathy (a weakened, enlarged heart) over several years to learn how genetics and heart scarring affect the disease. Participants give blood for genetic testing and have heart MRI scans. The goal is to improve diagnosis and pave …

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 at Boston Children's Hospital is testing whether a thorough catheterization assessment can predict the outcome of pulmonary vein stenosis in children. Eighty children with known or suspected vein narrowing will undergo four tests during catheterization: angiography, ul…

This study looks at how being in a hospital intensive care unit (ICU) after heart surgery affects your body's natural sleep-wake cycle. Researchers will track sleep patterns and thinking ability in 15 adults to see if disrupted rhythms slow down recovery. The goal is to understan…

This study aimed to see if using a special pad along with a standard closure device could help patients get out of bed sooner after a heart catheterization. It was planned for adults having the procedure through the groin. However, the study was withdrawn before any participants …

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…

This study follows 347 heart surgery patients to understand why some develop swallowing problems (dysphagia). Researchers will use special camera tests to watch how patients swallow and look for risk factors. The goal is to create simple tools that doctors can use at the bedside …

This study is following 10,000 adults who are having a heart MRI for medical reasons. Researchers want to see if the MRI results can help predict who will have heart problems in the future, like heart attacks or heart failure. The goal is to better understand how MRI scans can gu…

This study follows 50 people who had a minimally invasive procedure to widen a narrowed heart valve (pulmonary balloon valvuloplasty). The goal is to see how often the right side of the heart struggles afterward and what factors might predict that. Researchers will track changes …