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…
We are doing a study to learn more about the progression of knee osteoarthritis (OA). We are recruiting patients (Men 45-85 years old; Women 55-85 years old) who may or may not have OA of the knee(s). This study involves a screening and enrollment visit with annual visits for 3 years. Study activities include a hip and knee assessment, questionnaires, two…
The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood…
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
Depression and some antidepressants may be associated with an increased risk of breaking a bone. It is not clear why this could be the case. It is possible that depression and/or certain medications used for the treatment of depression cause bone loss, increase the risk of falls, are associated with lower physical activity, or effects on muscle function.…
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 is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
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, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
Precision Medicine Approaches to Renal Osteodystrophy is a study designed to discover new markers of how the kidney affects your bone health. This study will evaluate how your bone is reacting to your kidney problem both before and after you start your bone treatment for hyperparathyroidism or osteoporosis. We are looking for people who are interested in…
We are studying the causes of and potential treatments for pregnancy & lactation-associated osteoporosis (PLO). We know little about the clinical features, causes, and prognosis of PLO. Our goal is to define the clinical characteristics of PLO and better understand similarities/differences among the women. We are looking for women with fractures during/…
Pain is a natural response to injury to let us know there may be damage to our bodies. Pain is the way our body tells us that we must take care of ourselves. Chronic pain is different and lasts for a long time. In some cases, chronic pain remains without any sign of body damage. Today, there is no way for a doctor to measure someone's chronic pain or…
Ovaprene, is an experimental monthly non-hormonal intravaginal contraceptive being developed as a possible new method of birth control. It consists of a round piece of woven material surrounded by a soft, flexible rubber ring. The ring itself is made of a silicone rubber combined with the following ingredients: ferrous gluconate (a type of iron), Vitamin C…
The study is looking to evaluate levonogestrel butanoate as a possible new long-acting injectable for birth control. Levonogestrel butanoate is a type of hormone called progestin that has a long history of clinical use in a variety of birth control methods (e.g. pills, intrauterine devices, implants) and its efficacy and safety are well recognized. This…
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…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
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 goal of this study is to learn whether treatment with a safe, commonly used drug called ATENOLOL prevents bone loss in women after menopause. Who Qualifies? Healthy post-menopausal women who are between the ages of 50 and 75. You may not be eligible if you have certain medical conditions. What's Involved? If you are eligible, you will be assigned…
The shoulder joint is the most mobile joint in the human body, steered by a group of muscles and their respective tendons, together called the rotator cuff. A consequence of this mobility is a vulnerability to degradation, or wear and tear, of tendons and inflammation in the surrounding area. Our study aims to create biological samples and data bank to get…
This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
If you are a woman between the ages of 18 and 35, are pre-menopausal, sexually active and do NOT wish to become pregnant, you are invited to see if you may qualify for a research study. The purpose of this research study is to test the effectiveness of an investigational oral birth control pill. If you qualify, you will receive investigational study…
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 Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
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 this study is to evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
We are asking you to participate in this research study because you are a woman of child-bearing age or potential and interested in using an intrauterine device (IUD) for birth control for up to 5 years.
Juvenile fibromyalgia (JFM) is a cause of chronic, whole-body pain. The cause of JFM is unknown. One of the possible causes of JFM is a problem with nerves called "small fiber neuropathy." This is a problem where small nerve fibers in the skin are not working properly and patients can have pain as a result. Recent studies have found evidence of…
There are over 62 million US women in their child-bearing years, ages 15-44. Thirty-eight million use some form of contraception which included permanent sterilization (tubal ligation or vasectomyin male partner), contraceptive implants, intrauterine devices, injections, pills, patches, vaginal spermicides, and behavioral methods such as coitus interrupts…
The purpose of this study is to gather more information about how effective the St. Jude Medical (SJM) TMMasters Series 15mm Rotatable Mechanical Heart Valve (15mm valve) is at treating a child's condition, as well as collecting information about the safety of the valve. The childs surgeon will have determined that child will likely require the 15mm…
Do You Have a Mirena IUD? You may qualify for a study on the extended use of the Mirena IUD! You may qualify if you are 18 to 33 years old and had your Mirena placed in 2013. Compensation available for time and effort. Find out if you qualify!
The purpose of this study is to find out how safe and effective investigational birth control pill, LF111 may be as a contraceptive, how it affects women's menstrual bleeding patterns, and how long LF111 stays in women's bodies. Participants will take the new experimental birth control pill for one year, and will come to the medical center for 8…
The LOTUS Edge Valve System is intended to improve aortic valve function in symptomatic subjects with severe aortic stenosis who are at intermediate risk for standard surgical aortic valve replacement (SAVR), including those who have a bicuspid native valve. The study will include subjects presenting with symptomatic severe aortic stenosis who are…
This is a study looking to evaluate how well a new hormone-releasing Intrauterine Contraceptive called LevoCept works in healthy, sexually active women. The study will consist of 6 study visits including a screening visit prior to enrollment and monthly telephone calls over the course of a year. The study visits will vary but mostly consist of physical and…
Columbia University is conducting a contraceptive clinical trial looking at two intrauterine devices, one of which is investigational. Pre-menopausal women ages 16-40 who are generally healthy, sexually active, at risk for pregnancy, and are not at risk for sexually transmitted infections may qualify.
The purpose of this study is to assess the effectiveness of AG200-15 which is an investigational birth control patch. AG200-15 is an investigational birth control patch being developed for use by women who wish to use a skin patch to prevent pregnancy. It contains LNG (levonorgestral) and EE (ethinyl estradiol), which are female sex hormones and are active…
We are looking for people ages 65 and older to help us evaluate if an investigational drug improves muscle function, which can reduce risk of falls and fractures. To be considered for the study, you: 1. Must complete a pre-screening phone interview to assess your eligibility 2. If you are eligible, you will be invited to attend an in-person appointment at…
This study will look at the safety and effectiveness of a new hormonal IUD. This IUD is a small device that a clinician will place in your uterus. It contains a progestin (a hormone) that releases a small amount of hormone to prevent pregnancy. Once the device is in, you will come in for periodic study visits over the course of a year.
This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from…
This trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
This study is studying the effectiveness and safety of a new birth control pill. The pill contains two hormones, drospirenone (a progestin) and estetrol (an estrogen), which combine to prevent pregnancy. Scientists think that estetrol may be safer and have more benefits than other estrogen hormones. The study lasts about one year, and you will come in for 7…
This research study is for patients with severe aortic stenosis. Patients may be considered for this study if they have a diseased aortic heart valve and who are at low operative risk for standard (traditional) open-heart surgery for aortic valve replacement (TAVR).
The purpose of this study is to learn more about the bones in children who are short. This study will help to see if the bones of short children who have low levels of growth hormone or children who are short but have normal levels of growth hormone are any different from children of average height. Bones have spongy inner parts and harder outer parts and…
The goal of this study is to assess the safety and function of this new device to insert an artificial mitral valve. This study is for patients who are a high risk candidate for standard openheart surgery to treat their mitral regurgitation. The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery…
Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on…
This study has been designed to treat patients with a pulmonary conduit or valve that has a large amount of regurgitation or is too narrow and needs to be replaced.
The unintended pregnancy rate is rising despite increased availability and use of different types of emergency contraception (EC) pills. Few studies have addressed reasons for EC failure, yet such an investigation may allow researchers to better understand if EC can be used more successfully.Recently studies have shown that EC failure rates are higher in…
The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that issimpler than the open-heart procedure being used today and may be safer for patients who are at ahigher risk from conventional open-heart surgery. The device being studied would be implanted without the need for an open-heart procedure and without…