The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked…
This is a research study to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of inflammation in the process. If you participate, you will receive an experimental medication for your depression named ethyl eicosapentaenoic acid (ethyl EPA), an omega 3 fatty acid. You will…
The goal of this study is to examine how effective and well-tolerated a possible new treatment for individuals who injure themselves frequently will be. All research procedures can be done from home no in-person visits are required. We are studying a minimal-risk form of electrical brain stimulation called transcranial direct current stimulation, or tDCS.…
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. If you participate, you will have two different brain scans (MRI and PET scan). You will also have antidepressant treatment for free. We will then be able to see whether information on the brain scans connects with how people do on the medications. The…
We are trying to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, we are looking at the importance of dopamine signaling in the process. If you participate, you will have two different brain scans (MRI and PET scan). You will also have treatment for your depression with an FDA approved medication,…
This study is a double-blind and placebo-controlled study to assess its efficacy of the new drug Lumateperone for patients with Major Depressive Episodes associated with Bipolar I and Bipolar II disorder. Lumateperone is thought to exert its antidepressant effect through interaction with sereotogenic, dopaminergic, and glutamergic neurotransmitter targets.…
We will evaluate the D-cycloserine (DCS) and lurasidone with MRI measurement of brain responses to DCS. DCS is a drug that works on the same brain receptor as ketamine. DCS is not approved by the FDA for bipolar depression. Study participants will receive a dose of lurasidone or placebo in one MRI and a dose of DCS in another, followed by an optional follow…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…