The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory, left ventricular heart failure.

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

This is a prospective, multi-center, double-arm, randomized, single-blind, evaluator blinded clinical trial designed to assess the safety and efficacy of the SelfWrap for prophylactic treatment intended to improve clinical outcomes for CKD patients referred for vascular access creation surgery.

This study is enrolling subjects with coronary artery disease (blockages in the arteries that supply blood to the heart) who need to undergo a procedure called a Percutaneous Coronary Intervention (PCI) to open up a blocked heart artery. At times, a heart pump is used during a PCI to help reduce the work the heart during the procedure. This study is evaluating a heart pump called the KARDION CORY P4 pump. The KARDION CORY P4 pump is investigational meaning it has not been approved for commercial use by the Food and Drug Administration (FDA). This study will randomize subjects, meaning assign by chance, to receive either the KARDION CORY P4 pump or the Impella CP, which is commercially available.

Study participation will last about 30 days and include up to 6 visits. The study includes blood work, questionnaires, an electrocardiogram (ECG) - a tracing of the heart's electrical activity and an echocardiogram (Echo) - an ultrasound test of the heart.

Risks include risks related to the study device including bleeding, infection, and injury to the blood vessel where the device is placed. There are also risks related to study procedures. There may be benefit and the information learned may benefit others in the future.

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

This study is being conducted in women who are at least 22 years old,+ and will be undergoing either a unilateral or bilateral mastectomy with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction (initial insertion of a tissue expander on top of the chest wall muscle followed by change-over to a breast implant after a period of tissue expander inflation).

The purpose of this research study is to evaluate the safety and effectiveness of the Melodi Matrix. .

The Melodi Matrix is an absorbable mesh that contains antibacterial agents (medicines that fight infections caused by bacteria) and is wrapped around tissue expanders before being implanted. After approximately 9 weeks, the mesh will fully absorb into the body.

This study is enrolling subjects who are referred for a ventricular tachycardia (VT) ablation. VT is an abnormal heart rhythm that comes from the lower chambers of the heart. An ablation is a procedure to treat abnormal heart rhythms by identifying where the abnormal heart rhythm is starting and then scarring the tissue as a way to stop them. In this study the scars are being made by freezing the tissue. This is called cryoablation. This study will use the Adagio VT Cryoablation System (vCLAS™ Catheter and Console) to perform the cryoablation. This system is considered investigational meaning it has not been approved for use outside of this study by the Food and Drug Administration (FDA). Study participation will last about one year and include the following visits: screening/baseline, procedure, pre discharge, 1, 3, 6 and 12 months. There will also be a telephone call at day 7 post ablation procedure. The study will also collect data including medical history and medications, physical exam findings, data from the procedure, echocardiogram (ultrasound test of the heart, electrocardiogram or ECG (test that captures the electrical activity of the heart) and cardiac MRI. The primary study risks are those related to the ablation procedure including pain, abnormal heart rhythms, low or high blood pressure, and blood vessel or heart muscle damage. There is potential benefit as the procedure may eliminate the abnormal heart rhythm and the information gained may help others with this condition in the future.

The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.