The purpose of this clinical study is to see whether a medical device called the DiamondTemp Ablation Catheter (also called the DiamondTemp Ablation System) can restore the heart to a normal heart rhythm.The DiamondTemp Ablation System being evaluated in this research study is investigational because it is not approved by the FDA for the treatment of atrial fibrillation by radiofrequency ablation. The DiamondTemp System is like systems currently being used to treat atrial fibrillation with radiofrequency ablation including the control system that participants could be randomized to.
The purpose of this study is to evaluate the effect of an investigational study drug called macitentan, on the properties and function of the heart and on the blood pressure in the pulmonary arteries and to find out more about the safety of the study drug in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation. The study will compare macitentan with a placebo to see if taking macitentan is better than taking a placebo
The purpose of this research study is to evaluate the different ways to program a Cardiac Resynchronization Therapy Defibrillator (CRT-D) through the use of software built into the CRT-D system. A CRT-D does not cure heart failure, but many people who receive a CRT device notice that they feel better. The objective of the device programming required by the SMART CRT study is to provide heart failure therapy which improves heart function.
The purpose of this study is to evaluate the use of a non-contrast MRI for the assessment of the vasculature of the lower extremity anatomical regions. Patients eligible for this study must have been referred for a clinical contrast enhanced CT scan or an invasive catheter angiography. The overall image quality and diagnostic accuracy of the non-contrast MRI will be compared to current clinical standards of care, such as contrast enhanced MRI, CT, and invasive angiography.
For some patients with heart failure, we know that using a special pacemaker configuration called cardiac resynchronization therapy (CRT) can help them feel better and live longer. In fact, in these patients, we can see improvements in cardiac function with CRT as early as a few beats after we turn it on. However, some patients continue to be sick after CRT and ultimately require more help. Some of these patients will get a surgically implanted pump (called a left ventricular assist device, or LVAD) that does the work of their heart. We do not know if CRT continues to help (or may hurt) these patients. In this study, we will assess the effects of CRT in LVAD patients in the short term.
This is a prospective, multi-center, open-label trial conducted in the United States (US). The study is designed to collect real world data on subjects with heart failure who are receiving the CardioMEMS HF System. The CardioMEMS is an approved medical device. The CardioMEMS device is designed to provide current measurements of a specific heart pressure to physicians. This information will help guide medical therapy in order to help prevent heart failure hospitalizations.
The goals of this study are to understand the mechanisms behind the development of heart failure in children born with complicated heart defects consisting of a functional single pumping chamber, improve the ability to objectively measure cardiac function in these patients and determine the relationship of these pathophysiologic mechanisms to outcomes.
The purpose of this study is to determine which treatment is best for preventing stroke or systemic embolism in patients who have experienced at least one episode of SCAF (sub-clinical atrial fibrillation) detected by their pacemaker or ICD (intracardiac defibrillator) or ICM (insertable cardiac monitor) and also have other risk factors for stroke. Subjects will be randomly assigned to one of the two treatment strategies: apixaban or aspirin. Neither the subject nor the researcher will know which treatment the subject is assigned. Follow-up visits will occur every six months until the end of the study.
The purpose of this study is to find out more about how an investigational study drug called omecamtiv mecarbil, works in people with heart failure. Omecamtiv mecarbil is also known as AMG 423. Omecamtiv mecarbil is an investigational medicine that increases the heart's ability to pump. In this study, omecamtiv mecarbil will be compared to placebo.
The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. It will be a randomized, single blind (subject) trial. Subjects will be followed for two years and then annually for 3 years for a total of 5 years after implantation.