10
Participants
Start Date
March 8, 2025
Primary Completion Date
September 30, 2026
Study Completion Date
March 31, 2027
SmartWave Lithotripsy balloon
ntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer.
RECRUITING
Prince of Wales Hospital, Shatin
Peijia Medical Technology (Suzhou) Co., Ltd.
INDUSTRY
Prince of Wales Hospital, Shatin, Hong Kong
OTHER