Abbott Medical Devices

This study tests a new device called Tendyne, which is a replacement heart valve placed through a tube in the blood vessels, avoiding open-heart surgery. It is for people with a leaky mitral valve (mitral regurgitation) who are too high-risk for traditional surgery. The trial com…

This study tests a new device that uses shock waves to break up calcium deposits in heart arteries before placing a stent. About 335 adults with coronary artery disease will receive this treatment at up to 55 US sites. The goal is to see if the device helps stents work better and…

This study tests a next-generation heart valve (Navitor) in 333 people with severe aortic stenosis who are too high-risk for open-heart surgery. The goal is to see if the valve is safe and works well at 30 days, focusing on survival and reducing leaks around the valve. The valve …

This study tests a device called Amulet 2 that is implanted in the heart to seal off a small pouch (the left atrial appendage) where blood clots can form in people with atrial fibrillation. The goal is to reduce the risk of stroke without needing long-term blood thinners. About 4…

This study is testing a device called the Tendyne mitral valve system in 200 people with mitral regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The valve is implanted through a tube in an artery, avoiding open-hear…

This study is tracking 511 patients with severe tricuspid regurgitation who are treated with the Abbott TriClip device in real-world settings. The main goal is to see if the device can successfully reduce the valve leak by at least one grade at discharge. Researchers are also mon…

This study is checking how safe and well a device called TriClip works for people with a leaky heart valve (tricuspid regurgitation). The device is already approved for use, and this study will watch 1000 adults who get it to see how they do. The goal is to make sure the device w…

This study tests if a device called MitraClip, which fixes a leaky mitral valve without open-heart surgery, works as well as traditional surgery. About 500 people with severe mitral regurgitation who are at moderate risk for surgery will take part. The goal is to see if the devic…

This study tests a new device called the Navitor TAVI system to replace a stiff, narrowed heart valve without open-heart surgery. It includes 1,500 people with severe aortic stenosis who are at low or intermediate risk for surgery. The goal is to see if the device is safe and eff…

This study tests a new device system that uses pulsed electric fields to treat atrial fibrillation, a common heart rhythm problem. About 300 people with symptomatic, recurrent atrial fibrillation will receive the procedure. The goal is to see if it safely and effectively restores…

This study is testing a small mechanical heart valve (15mm) in 20 children who need their aortic valve replaced due to disease or damage. The valve is designed to last and is monitored for safety and function over 5 years. Children will need lifelong blood-thinning medication to …

This study tests a new heart valve called the NAVITOR, placed using a thin tube (catheter) without open-heart surgery. It includes 434 people with severe aortic stenosis who are at intermediate or low risk for surgery. The main goals are to check for leaks around the valve at 30 …

This early study is testing a new balloon-expandable heart valve device (TAVI) in 8 people with severe aortic stenosis who are at increased surgical risk. The goal is to see if the device can be safely delivered and perform as intended. Because this is a first-in-human study with…

This study is testing a new type of pacemaker that doesn't use wires (leads) to help control slow heart rhythms. About 20 adults who need a pacemaker will get this device and be checked for safety and how well it works at 1 and 3 months. The goal is to see if this leadless system…

This study follows about 200 people with chronic limb-threatening ischemia (CLTI) who receive the Esprit BTK System, a dissolvable scaffold coated with a drug to keep leg arteries open. The goal is to see how safe and effective it is in routine medical practice. Researchers will …

This study tests a new type of wire (lead) for implantable heart devices like ICDs or CRT-Ds. The lead is designed to pace the heart's natural conduction system, which may work better than standard pacing. About 414 adults who need these devices will be followed for 3 months to c…

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 looks at a special stent (a small mesh tube) coated with the drug everolimus, designed for large coronary arteries. It involves 102 people with coronary artery disease who need a stent. The goal is to see how safe and effective the stent is in everyday medical practice…

This study tests if a device that closes a small pouch in the heart (left atrial appendage) is safer and more effective than long-term blood thinners for preventing strokes in people with atrial fibrillation. About 2,650 participants with AFib and high stroke risk are randomly as…

This study tests a special plug device to close leaks that can form around surgically implanted heart valves. These leaks can cause serious problems like heart failure or anemia. The procedure is done through a catheter, avoiding the need for another open-heart surgery. The study…

This early study is testing a new balloon-expandable heart valve system from Abbott for people with severe, symptomatic aortic stenosis. The valve is delivered through a catheter, avoiding open-heart surgery. Only 11 participants are enrolled to check if the device is safe and wo…

This trial tests a special device called the Esprit BTK, which is a tiny mesh tube coated with a drug that helps keep leg arteries open. It is for people with critical limb ischemia, a serious condition where blocked arteries cause pain and wounds. About 261 participants will rec…

This trial studies whether a special pacing feature called SyncAV, used in heart devices, can improve heart function in people with congestive heart failure. About 1,686 participants will get a new or upgraded heart device and be randomly assigned to have SyncAV on or a standard …

This study follows 200 people with persistent atrial fibrillation (AF) who undergo a heart procedure using Abbott's ablation catheter. The catheter uses heat to scar tiny areas in the heart and block faulty electrical signals. Researchers track how many patients stay free of AF f…

This study follows 62 people with non-ischemic structural heart disease who have recurrent, drug-resistant ventricular tachycardia. They are treated with the FlexAbility SE ablation catheter, which uses heat to destroy small areas of heart tissue causing the abnormal rhythm. Rese…

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 observes over 600 people with atrial fibrillation who received the Amulet device to close a part of the heart called the left atrial appendage. The goal is to see how well the device prevents strokes and bleeding in everyday medical practice. Participants are followed …

This study follows over 3,400 people who have already received the Aveir VR leadless pacemaker, a small device placed directly in the heart to treat slow heart rhythms. Researchers are using real-world medical records to check for complications up to 10 years after implantation. …

This study enrolls 80 people with implanted heart devices to see if collecting extra health data from wearables and a phone app can improve care. Participants must have had a heart failure event in the past year. The goal is simply to gather data, not to test a new treatment.

This study tracks how much of a drug called everolimus enters the blood after placing a special coated device (Esprit BTK) in leg arteries of people with severe blocked leg circulation (critical limb ischemia). About 7 participants will have blood samples taken over 60 days. The …