Treating severe mitral valve calcification with a specialized balloon
Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study
This study is testing a special balloon treatment for people with severe mitral valve calcification to see if it can help them feel better when other options aren't safe or effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT06952374 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the SmartWave Lithotripsy balloon in treating severe mitral valve annular or valvular calcification, particularly in patients with symptomatic mitral stenosis. The study focuses on patients who have severe calcification that makes traditional balloon valvuloplasty risky or ineffective. By using intravascular lithotripsy, the trial seeks to facilitate the opening of the stenotic mitral valve, potentially improving patient outcomes. The approach is designed for patients who are not suitable candidates for conventional treatments due to the severity of their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with severe symptomatic mitral stenosis and significant mitral annular calcification or chronic rheumatic heart disease.
Not a fit: Patients with moderate or greater mitral regurgitation, intracardiac thrombus, or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and outcomes for patients with severe mitral valve calcification.
How similar studies have performed: Previous studies have shown success with the off-label use of lithotripsy balloons in treating calcified lesions, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kent So, MbChB — Chinese University of Hong Kong
- Study coordinator: Daniel Xu, Nursing Officer
- Email: danielxu@cuhk.edu.hk
- Phone: 85235051518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.