This study is testing a new treatment for people with a dangerous heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, leading to fainting, heart failure, or even sudden death. Some people continue to have VT even after taking medicines and undergoing standard ablation procedures. For these patients, current treatment options are very limited.
The investigational treatment uses the Thermedical Ablation System with the Durablate™ catheter. This device delivers both heat and saline (salt water) deep into the heart muscle to target the areas causing abnormal rhythms. The goal is to safely and effectively reduce or eliminate VT episodes in patients who have not responded to other therapies.
About 130 patients will be enrolled at up to 25 hospitals in the U.S. and Canada. Participants will have the procedure and then be followed for six months with regular checkups to see if the treatment reduces their VT episodes and improves their quality of life. This study will help determine if the new system should be approved for wider clinical use.
Genicular Artery Embolization (GAE) is a newer treatment aimed at reducing knee pain caused by osteoarthritis by targeting and reducing inflammation. In people with knee osteoarthritis, inflammation in the joint leads to the growth of tiny new blood vessels, called neovessels. These vessels are not normally present in a healthy joint and contribute to ongoing inflammation and pain.
GAE works by selectively injecting tiny particles into specific arteries that supply blood to these abnormal vessels. This process is called embolization, and it temporarily blocks the flow of blood through the neovessels.
Doctors use a special imaging technique called angiography to guide the procedure. This allows them to see the inflamed area and locate the neovessels, which are larger than normal due to the ongoing inflammation—usually about 1–2 millimeters in diameter.
By blocking these abnormal vessels, GAE helps to reduce the number of inflammatory cells and signaling chemicals (called cytokines) that enter the joint through the bloodstream. This decreases the overall inflammation in the area.
Additionally, the growth of pain-sensing nerves, which often occurs alongside these new vessels, may also be reduced. These nerves—called unmyelinated sensory nerves—can worsen pain when they are activated by inflammation. By decreasing both inflammation and nerve growth, GAE may significantly reduce knee pain in people with osteoarthris
The FDA has not currently approved the study device. Patients will undergo 8 visits over a 12 month period. screening, screening 2,treatment, 30 day follow up,90 days,180,270,365 follow up.
The investigational varicella vaccine (hereafter referred to as VNS vaccine) is a new
candidate varicella vaccine derived from the Oka strain. The main rationale for the
development of VNS vaccine is to provide an additional alternative varicella vaccine as an advantage from a public health perspective to prevent varicella disease