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…
Are you suffering from persistent symptoms that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new research study aims to test a new form of treatment for people with persistent symptoms despite antibiotic treatment for Lyme disease. This treatment involves stimulating a nerve on the surface of your ear. This is called…
Have you been treated for Lyme Disease but continue to have brain fog or other cognitive problems? This research study will assess a non-medication non-invasive intervention to improve cognitive functioning in people with persistent cognitive problems despite prior antibiotic treatment for Lyme Disease. Participants will complete this 4 week intervention at…
This patient case registry for Lyme and other Tick-borne Diseases is a component of the Clinical Trials Network that was launched in 2021 by a grant from the Steven and Alexandra Cohen Foundation. The registry will gather general information such as demographics, medical history, and current functional status. This information will help researchers to…
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…
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be…
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…
We are asking you to participate in a research study to learn if different ways of doing routine anesthesia and patient care before, during and after abdominal surgery can reduce breathing problems. The total time of the study is 3 months with daily visits by a member of our study team while you are in the hospital and 3 short follow-up calls after you…
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.
Are you suffering from chronic fatigue that began after you were diagnosed and treated with antibiotics for Lyme Disease? This new treatment research study investigates whether disulfiram, commonly known as "Antabuse", has the potential to be used as a treatment option for patients experiencing chronic post-treatment Lyme symptoms. This well-known…
You are being asked to be part of this study because you have been diagnosed with a bulge or aneurysm in your iliac arteries, the vessels that supply blood to the lower half of your body. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk…
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 CDC estimates that 10-20% of patients with Lyme disease will go on to have chronic symptoms despite having had appropriate treatment, a condition known as Post-Treatment Lyme Disease Syndrome (PTLDS). While there is currently no known cure, various therapies are being investigated. One promising approach is the practice of meditation and yoga which have…
The study is designed to evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for a full thickness Massive Rotator Cuff Tears (MRCT) in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
The purpose of this research study is to compare the safety and effectiveness of two drug-eluting stents that are used to open the blocked or narrowed blood vessel of the leg in patients with Peripheral Artery Disease (PAD): the ELUVIA Stent and the Zilver PTX Stent.
Thepurposeof the study is to test whether or not QPI-1002 could be used to lessen or prevent acute kidney injury after heart surgery. Another purpose is to better understand the safety of QPI-1002.
The purpose of this study is to evaluate the short-term (1 year) and long-term (5 and 10 year) safetyand effectiveness of the JOURNEY II CR Total Knee System in patients with degenerative joint disease of the knee requiring primary total knee replacement. Clinical, radiographic, and health economic outcomes will be evaluated.