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.
This study is for patients who have severe migraine headaches that might be a result of a hole in the heart wall called a Patent Foreman Ovale, or PFO. It is known that as many as 40% of patients with migraine headaches also have a PFO. It is not well understood how the two are related, or how having a hole in the heart wall could cause headaches. In this…
This study plans to learn more about a device called the Cefaly and if it is effective for treating migraine attacks. This device is approved by the Food and Drug Administration (FDA) for the prevention of episodic migraines, but clinical data has not yet been collected on its effectiveness in treating migraine attacks. The Cefaly device works by generating…
This study is for patients with Glaucoma. The purpose of this study is to investigate the safety and effectiveness of a study drug called Bimatoprost Sustained Release (SR) compared to treatment with eye drug Timolol. The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug.
The ENFORCE Teva Cluster Headache clinical trial is looking for people who have been diagnosed with episodic cluster headaches to participate. People who volunteer and qualify may have the opportunity to try an investigational study drug for cluster headaches. If you're 18 to 70 years old and have experienced cluster headaches for 12 months or more,…
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening…
Glaucoma is a given name of a group of diseases that affect the retinal ganglion cells in the eye and the optic nerve. Glaucoma cause degeneration of the retinal ganglion cells in the retina and their projections (axons) that form the optic nerve. Retinal ganglion cells and their axons transmit all of our vision information from the eye to the brain through…
If so, you may be able to take part in a clinical research study. This study is being done to see how wellcarbon dioxide (CO2) may provide relief from the pain associated with Trigeminal Neuralgia (TN). CO2 is a gas that is part of the air we breathe and is used to make bubbles in carbonated drinks. The screening and treatment office visit can be done in…
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…
This study plans to learn more about a device called the Cefaly and if it is effective for treating migraine attacks. This device is approved by the Food and Drug Administration(FDA) for the prevention of episodic migraines, but clinical data has not yet been collected on its effectiveness in treating migraine attacks.