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

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.

This study is enrolling two different groups of individuals. The first group are those individuals referred for right heart catheterization (RHC), which is a procedure performed to check heart pressure taken inside the heart. The second group of individuals are those who have tricuspid regurgitation (TR) (blood that leaks due to improper valve closure) and are undergoing tricuspid valve intervention to correct the regurgitation. The RHC group will be referred to as the control group and the tricuspid intervention group will be the treatment group in this study. This study involves collecting existing medical records on both groups, as well as an arterial (from an artery) blood sample and venous (from a vein) blood sample from the vein that carries blood away from the liver. The control group will not involve any additional procedures or follow up. The TR population will perform a 6 minute hall walk test before their tricuspid valve intervention and again during the six month post procedure follow up. The TR group will also have repeat arterial and venous blood collection at the six month follow up. The TR group will have data collected for up to two years post tricuspid valve intervention.

You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.

The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.

Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the VDyne Transcatheter Tricuspid Replacement System will be used to treat the tricuspid regurgitation. The VDyne Transcatheter Tricsupid Replacement System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study all eligible participants will be treated with the device.

Participation in this study will last about 5 years and involve up to 13 visits. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

There are risks associated with this study including potential risks with the device, implant procedure and study related procedures. There is also the risk of loss of confidentiality. The study may or may not benefit you but the information learned may benefit others with this condition in the future.

This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.

Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years