Actively Recruiting
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Led by Prince of Wales Hospital, Shatin, Hong Kong · Updated on 2025-04-30
10
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
P
Prince of Wales Hospital, Shatin, Hong Kong
Lead Sponsor
P
Peijia Medical Technology (Suzhou) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated. SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.
CONDITIONS
Official Title
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Able to provide consent for the procedure and study participation
- Severe symptomatic mitral stenosis with mitral valve area less than 1.5 cm² by 3D planimetry, continuity equation, or pressure half time
- Presence of mitral annular calcification or
- Chronic rheumatic heart disease with severe leaflet calcification and Wilkins score over 8
You will not qualify if you...
- Moderate or greater mitral regurgitation at baseline
- Presence of intracardiac thrombus as seen by transesophageal echocardiogram
- Pregnancy or positive pregnancy test within 7 days before the procedure
- Active infection with bacteremia
- Current participation in another investigational drug or device study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong, 999077
Actively Recruiting
Research Team
D
Daniel Xu, Nursing Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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