Glaucoma is the leading cause of permanent blindness in the world, often due to the intraocular pressure in your eye (IOP) becoming too high. Cataracts are the cloudy lenses inside your eye that are common after age 40 and often require surgery to replace the cloudy lens with an intraocular implant (IOL). This study will evaluate the safety and IOP-lowering effectiveness of the DF12 Canaloplasty and Trabeculotomy Surgical System. This device combines two glaucoma surgical procedures (Canaloplasty and Trabeculotomy) in patients that are having their cataracts removed. The endpoint for this study is the reduction in IOP without the use of topical (often eye drops) or oral glaucoma medications at 12 months.

The purpose of this research is to evaluate the safety and effectiveness of the EchoMark/EchoSure System for AVF (arteriovenous fistula) for assessing AV fistula maturation when used under a protocol of biweekly use as compared to the standard of care follow-up. Target subject population are subjects presenting with Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) undergoing upper arm autologous arteriovenous fistula creation for hemodialysis access who are on dialysis or will imminently require dialysis (GFR <10).

This is a prospective, multicenter, observational study designed to evaluate the clinical utility and prognostic relevance of serial TRAC and T-ID monitoring in kidney transplant recipients under routine clinical care.

Adult subjects with rectal cancer undergoing sphincter sparing resection and colonic anastomosis. Post-operative follow-up will occur at 7-10 days, 30 days, 90 days, 180 days, and 270 days.

This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.

This study is enrolling patients with severe tricuspid regurgitation. Tricuspid regurgitation happens when your heart's tricuspid valve does not close tightly. The study will look at the safety and function of the investigational VDyne Transcatheter Tricuspid Replacement System (VDyne System). The VDyne System (Study Device) is experimental, which means it is not approved by the Food and Drug Administration (FDA), or any other relevant regulatory authority for commercial use. The VDyne System consists of an artificial heart valve and tools to place the valve into your heart. The VDyne Valve is designed to replace your tricuspid heart valve without open-heart surgery.

This study is randomized, meaning you will be assigned by chance to receive either the Study Device or the EVOQUE system, which is commercially approved by the FDA. The EVOQUE System is approved for use in the European Union (EU) (CE Mark) and the US (FDA).

Participation in this study will last about 5 years and include about 11 visits. Study related procedures included in these visits are physical exams, questionnaires, walking and moving from sitting to standing tests, blood tests, electrical measure of your heart's performance, ultrasound imaging of your heart, insertion of a thin tube to measure pressures through a blood vessel and monitor blood flow through your heart, and X-rays.

There are risks associated with the study such as: bleeding, injury to the system that controls your heartbeat, movement of the VDyne Valve from its implanted location, irritation of your esophagus, pain, inflammation, and skin/tissue injury. There are also risks related to study procedures such as other risks related with putting you to sleep for the procedure (general anesthesia) or other study related testing risks and the loss of confidentiality. Not all risks are known at known at this time. There may be benefit to you, although this cannot be guaranteed, but the information gained from you being in this study may benefit others with this condition in the future

The purpose of this research study is to evaluate the safety and effectiveness of a
physician-modified endograft (tubular medical device used to reinforce weakened or damaged blood vessels) for repairing serious diseases of the aorta (largest artery in the human body, responsible for blood from the heart to the rest of the body). This device is considered investigational, and this research study received an Investigational Device Exemption (IDE) from the FDA.

This will be a retrospective chart and imaging review of the patients who have undergone this procedure since its inception. From the patient charts, we will collect demographic and surgical information. From their imaging, we will collect pre- and postoperative radiographic measures to assess whether adequate distalization has been achieved. Patients that have received this surgery and are willing to provide patient reported outcomes will be contacted and asked about post-operative pain, functionality, and satisfaction.

This is a post approval study for those being implanted with the WiSE System. Data will be collected from your medical records including medical history, medications, the implant procedure, and device check as well as routine follow up visits, and you will be asked to complete a questionnaire at 3 visits. Participation in this post approval registry will last about 5 years. There is a risk of loss of confidentiality.

This study is enrolling subjects with severe aortic regurgitation (when blood leaks back in the heart because the aortic valve does not close properly) into a randomized study. Typically valve replacement is performed to correct this condition. This study will compare a transcatheter aortic valve replacement (TAVR) using the JenaValve Trilogy Heart Valve System to open heart aortic valve surgery (SAVR). the JeneValve Trilogy Heart Valve System is considered investigational meaning it has not been approved yet by the Food and Drug Administration (FDA). A TAVR procedure is done by accessing a large blood vessel at the top of your leg and delivering the new valve as opposed to open heart surgery. This study will randomize subjects in a 1 to 1 fashion to TAVR or SAVR. Randomized means assigned by chance, so you will have a 50% chance of being assigned to the TAVR group and a 50% chance of being assigned to the SAVR group. The SAVR group will have the aortic valve replacement done by open heart surgery using a commercially available device.

Participation in this study will last about 10 years and include 15 visits. Study related testing includes physical exam, echocardiograms (ultrasound test of the heart), electrocardiograms (recording of heart's electrical activity), 6 minute hall walk, bloodwork and a questionnaire.

There are risks including risks related to the procedure and to study testing. There may be no benefit but the information learned may help in treating others in the future.