Heart valve replacement without on-site surgery for high-risk patients

This trial is testing a minimally invasive procedure called transcatheter aortic valve implantation (TAVI) for patients with severe narrowing of the aortic heart valve who cannot safely undergo traditional open-heart surgery. Instead of opening the chest, doctors insert a new valve through a catheter in the groin and guide it to the heart. The study will follow about 200 patients to see how safe and effective this procedure is when performed in hospitals that don't have cardiac surgery available on-site.

Many elderly and very frail patients with severe aortic valve disease cannot have traditional surgery because of their age, overall health, or other serious medical conditions. This trial exists to see whether the minimally invasive catheter-based approach can safely and effectively treat these high-risk patients at hospitals without immediate access to surgical backup.