Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study

What this Trial Is About

Mitral stenosis (MS) is a serious heart valve condition often caused by chronic rheumatic heart disease or mitral annular calcification (MAC). Current treatments like balloon valvuloplasty work well for some but are risky for patients with severe valve calcification, which can cause complications such as severe mitral regurgitation. Open-heart surgery for MAC also carries high risks, and newer transcatheter valve replacement options have limitations and risks. This study explores a new approach using a specialized lithotripsy balloon designed to treat calcified mitral valves more safely and effectively. The study evaluates the SmartWave lithotripsy balloon, a device originally made for aortic valve calcification, applied here for the first time to treat calcified mitral stenosis caused by MAC or severely calcified rheumatic valves. Lithotripsy uses sound waves to break up calcium deposits while sparing soft tissue, potentially improving valve flexibility and making subsequent procedures safer. This first-in-human trial will investigate using the SmartWave balloon to prepare the mitral valve before balloon valvuloplasty or valve replacement. Participants will undergo treatment with the SmartWave balloon, and researchers will monitor improvements in valve area and check for complications during and after the procedure. Follow-up assessments over 12 months will include heart function tests, symptom questionnaires, imaging to track calcification changes, blood markers, and potential cardiac events. The study aims to gather detailed safety and effectiveness data while closely observing participants throughout the year after treatment.

Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE