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Study identifier: NCT06952374 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Mitral Annulus Calcification · Rheumatic Heart Disease  ·  Sponsor: Prince of Wales Hospital, Shatin, Hong Kong

PhaseNA
Planned participants10
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC). Current guideline recommends percutaneous balloon mitral valvuloplasty (PBMV) being the first line intervention for rheumatic MS with favorable anatomy. However, severely calcified mitral valve (i.e. those with Wilkins scores\>8) makes the mitral valve non-pliable and carries high risk of severe mitral regurgitation (MR) (4-19%) with conventional balloon valvuloplasty. MAC is an increasingly recognized disease associated with atherosclerotic risk factors, and a well-recognized valve morphology that responses poorly with PBMV. Besides, conventional open-heart surgery for MAC-associated mitral valve dysfunction carries high mortality. Transcatheter mitral valve replacement with valve-in-MAC has become an alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality. Intravascular 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 l…

This description comes directly from the study's public registry record.

Talk to the study team

Daniel Xu, Nursing Officer  ·  85235051518  ·  danielxu@cuhk.edu.hk

Always discuss trial participation with your own doctor first.

Locations (1)

Prince of Wales HospitalShatin, New Territories, Hong KongRecruiting

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Source record: clinicaltrials.gov/study/NCT06952374