This study will examine whether a baroreflex activation therapy device (a small pacemakers that are helpful in heart failure) is beneficial for left ventricular assist device (LVAD) patients. For patients who have a baroreflex activation therapy device and LVAD, we assess whether baroreflex activation therapy helps them feel better and have fewer symptoms. We will also look at whether it helps with recovery of their weak heart. Participation in this study will last 6 months and require 3 clinic visits. At each visit, a participant's symptoms will be assessed, they will have pictures of their heart taken to determine function, and bloodwork will be drawn.
This study is enrolling participants who are already implanted with a S-ICD device (Subcutaneous Implantable Cardioverter Defibrillator, which is a device designed to monitor heart rhythms and deliver a shock to the heart to stop life threatening heart rhythms), and are undergoing a routine outpatient clinic follow up appointment to have their S-ICD checked. The aim of the study is to see if a feature in the device can recognize muscle movement and differentiate movement from irregular heart signals. The study involves doing some simple arm exercises while collecting device data, both with this feature turn on and then with it turned off. Participants will be randomized to either have the feature turned on or off initially then it will be programmed the alternative way and the same exercise testing will be repeated. The study will involve just one visit.
This study's objective is to determine if electrical stimulation can safely reduced atrial fibrillation, which is an abnormal heart rhythm that begins in the top chambers of the heart. Electrical stimulation will be delivered to the wrists or in the ear. Participation will last about 6 weeks and require 3 clinic visits. Participants will be asked to wear a heart monitor and patch to monitor the heart rate and rhythm, keep a diary to collect information on atrial fibrillation, undergo randomization (being randomly assigned, like drawing straws) and use the study device per randomization assignment. Participants are randomized in a 1:1:1 fashion to a wrist worn study device, an ear piece study device or a sham wrist worn study device. A sham device looks like the real wrist worn device but does not deliver any electrical stimulation.
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.
Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.
This study will involve taking one or two medications already approved by the Food and Drug Administration (FDA) for treatment of type 2 diabetes to learn more about which diabetes medications are the best for lowering the risk of heart and kidney disease in individuals with type 2 diabetes who are at least 40 years old. Participation includes about 8 study visits over a period of 72 months, which can be performed over the phone remotely or during normal standard of care clinic visits. Participants will be compensated for their time and participation in this research study.
The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.
This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.
The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 66:33 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.
The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.