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 seeking subjects who have been diagnosed with and may be receiving medical treatment for mitral valve disease. The purpose of this registry is to collect data to better understand the progression of mitral valve disease and the effects of different treatments on the disease and patient health. If you agree to participate in this registry, your medical data will be collected including your medical history, certain background information, and certain test images/results. This registry will also collect information about current and future treatments for your mitral valve disease and data from future disease-related follow-up visits. Data will be collected for up to 24 months. There are no additional visits or any additional testing required for this registry.
This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.
A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.
Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.
Risks include infection, scarring, and bleeding. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.