Abbott Medical Devices

This study tests a new heart valve device (Navitor TAVI) for people with severe aortic stenosis, a condition where the heart's main valve becomes narrow. It includes 1,500 participants who are at low or intermediate risk for surgery. The goal is to see if the device is safe and e…

This study tests a new heart valve (Navitor) placed without open-heart surgery in 434 people with severe aortic stenosis. The main goals are to check for leaks around the valve at 30 days and to see if the procedure reduces death or disabling stroke at one year. Participants are …

This study tested a new device called the Tendyne Transcatheter Mitral Valve System to treat people with a severe leaky heart valve (mitral regurgitation). About 103 participants received either the Tendyne device or another approved device. The goal was to see if the new valve i…

This study tests a new balloon-expandable heart valve system from Abbott for people with severe aortic stenosis, a condition where the heart's main valve is narrowed. The goal is to see if the device is safe and works as intended. Eleven adults with severe symptoms are taking par…

This early study tests a new balloon-expandable heart valve system in 8 people with severe aortic stenosis who are at increased surgical risk. The goal is to see if doctors can successfully deliver and use the valve. This is a first-in-human study, so it focuses on safety and how…

This study looks at a small mechanical heart valve (15mm) designed for children who need their aortic valve replaced. About 20 kids will get the valve and be followed for 5 years to check for serious side effects like blood clots, bleeding, or valve failure. The goal is to see if…

This study looks at a device used to close a common heart hole (PDA) in small babies, including those weighing as little as 700 grams. Researchers are tracking how safe the device is and how well it works over 6 months. The goal is to make sure the device is safe and effective fo…

This study tests a new device (TactiFlex SE catheter and Volt generator) that uses pulsed field ablation to treat paroxysmal atrial fibrillation, a type of irregular heartbeat. About 188 people with symptomatic AFib that hasn't responded to medication will receive the procedure. …

This study tests whether a less invasive device called MitraClip works as well as open-heart surgery to fix a severe leaky heart valve (mitral regurgitation) in people who are at moderate risk from surgery. About 500 participants will be randomly assigned to get either the clip o…

This study looks at how well a large heart stent (XIENCE Skypoint) works in people with coronary artery disease. About 102 participants received the stent to open blocked arteries. Researchers track safety and effectiveness, such as heart-related death or need for repeat procedur…

This study looks at a special device called the Esprit BTK scaffold, which slowly dissolves over time, to treat blocked arteries below the knee in people with chronic limb-threatening ischemia (CLTI). About 200 patients will be enrolled at up to 50 hospitals. The goal is to see i…

This study looks at whether a special pacing feature called SyncAV helps people with congestive heart failure more than standard pacing. About 1,686 people who need a new heart device will be randomly assigned to get SyncAV or regular pacing. The main goal is to see if the heart'…

This study tests a special drug-coated device (Esprit BTK) to open blocked arteries below the knee in people with critical limb ischemia, a severe condition that can lead to amputation. About 261 participants received either the device or standard treatment. The goal is to see if…

This study tests a new type of wire (lead) for implantable heart devices like ICDs and CRT-Ds. The lead is designed to pace a specific part of the heart's natural electrical system, which may improve heart function. About 414 adults who already need an ICD or CRT-D will get this …

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 tests a new system that uses short bursts of energy to fix irregular heartbeats (atrial fibrillation) in 300 people. The goal is to see if it safely restores a normal rhythm without needing lifelong medication. Participants have symptoms that haven't improved with drug…

This study compares two ways to prevent strokes in people with atrial fibrillation (an irregular heartbeat). One group gets a device called the Amulet that plugs a small pouch in the heart where clots can form. The other group takes standard blood-thinning medication (NOACs). The…

This study looks at a special catheter (FlexAbility SE) used to treat a fast, dangerous heart rhythm called ventricular tachycardia. Researchers followed 62 people with heart disease to see if the catheter is safe and works well over 12 months. The goal is to control the conditio…

This study looks at a device called the AMPLATZER PFO Occluder, which is used to close a small hole in the heart (PFO) that can cause strokes. Over 1,200 people who had a stroke in the past 18 months and have a PFO took part. The goal is to see if the device is safe and helps pre…

This study follows 200 people with persistent atrial fibrillation (a type of irregular heartbeat) to see how well a catheter-based treatment called radiofrequency ablation works over time. The treatment uses a special catheter to zap tiny areas in the heart that cause the faulty …

This study tests a device called Amulet 2 that plugs a small pouch in the heart (the left atrial appendage) where clots often form in people with atrial fibrillation. The goal is to lower stroke risk without needing lifelong blood thinners. About 458 participants with AF and high…

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

This study is testing a small plug device to seal leaks that can develop around surgically replaced heart valves. The device is delivered through a catheter to avoid another major open-heart surgery. Researchers aim to see if this procedure is safe and effective at reducing the l…

This study looks at how a drug-coated device (Esprit BTK) releases medication into the blood after being placed in leg arteries below the knee. About 7 people with severe leg artery disease (critical limb ischemia) will have their blood tested at many time points over 60 days. Th…

This study is collecting extra health information from wearable devices and a smartphone app to see if it can help improve care for people with heart disease. About 80 adults who already have a special heart device (CRT-D) and have had a heart failure event in the past year will …