Status:
RECRUITING
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Lead Sponsor:
Prince of Wales Hospital, Shatin, Hong Kong
Collaborating Sponsors:
Peijia Medical Technology (Suzhou) Co., Ltd.
Conditions:
Mitral Annulus Calcification
Rheumatic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 reco...
Detailed Description
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 reco...
Eligibility Criteria
Inclusion
- Age \>18 and
- Able to give procedure and study consent and
- Severe symptomatic mitral stenosis (MVA \<1.5cm\^2 derived by 3D planimetry or continuity equation or pressure half time) and
- Presence of mitral annular calcification or
- CRHD with severe leaflet calcification with Wilkins score \>8
Exclusion
- Baseline \> moderate MR
- Intracardiac thrombus as visualized by TEE
- Pregnant patients. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- Active infection with bacteremia
- Current participation in another investigational drug or device study
Key Trial Info
Start Date :
March 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06952374
Start Date
March 8 2025
End Date
March 31 2027
Last Update
April 30 2025
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong, 999077