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 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.
The purpose of this study is to determine if Acthar gel is a safe and effective therapy for patients with membranous (Class V) lupus nephritis. Class V lupus nephritis is associated with the development of chronic kidney disease and end-stage renal (kidney) disease, and there is no clear therapy for treatment. Currently used therapies arent completely…
Meniere's Disease is an inner ear disorder that causes episodes of vertigo. The purpose of this study is to test the effectiveness and safety of OTO-104 compared to placebo in subjects with Menieres disease. OTO-104 contains an active ingredient, called dexamethasone, which is a commonly used corticosteroid that has been prescribed by doctors for…
This study is for patients who have been diagnosed with systemic Lupus erythematosus (SLE). SLE is a disease in which the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. The purpose of this study is to test the effects of an investigational (being tested) study drug, CC 220, in order to find out if CC…
The purpose of this clinical trial is to learn about the ability of an experimental treatment XmAb5871 to maintain lupus disease activity improvement achieved by a brief course of disease-suppressing intramuscular (IM) steroid therapy in lupus patients.
The purpose of this study is to evaluate the safety and tolerability of an experimental investigational drug called ixazomib citrate (MLN9708) in patient with Lupus Nephritis. Lupus nephritis is a condition when the kidney is affected in the autoimmune disease known as systemic lupus erythematosus (SLE). SLE is a disease in which the immune system (the body…
If you have active Systemic Lupus Erythematosus, also known as SLE or Lupus, you may be interested to learn about a clinical research study that is being conducted to study the safety and effectiveness of an investigational medication called ustekinumab for active Lupus. Eligible study participants will be provided with study medication and study-related…
We are studying a medication to see if it is effective in reducing the disease activity of systemic lupus erythematosus (SLE), which is the most common form of lupus. You may qualify for the Achtar study if you have persistently active SLE, are 18 years of age or older, and: Have rash and/or arthritis as part of your SLE symptoms Are currently taking…
The purpose of this study is to test the safety and effectiveness of the study drug Obinutuzumab and to find out what effects, good or bad, it may have as an additional therapy in treating your lupus nephritis symptoms.
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…
The purpose of the study is to find out if study drug belimumab is safe and effective in treating children with active lupus who are also taking other lupus medicine. Belimumab (also known as BENLYSTA hasbeen approved in the United States, Canada, and Europe for the treatment of adults with active SLEwho are receiving other lupus medicines but not yet…
The goal of this study is to test a new lupus drug. This drug interrupts the function of a chemical in the body called IL-6, and IL-6 may be overactive in people with lupus. ALX-0061 is a study drug that will be administered subcutaneously to subjects with moderate to severe active, seropositive Systemic Lupus Erythematosus (SLE) compared to placebo.