Treating severe mitral valve calcification with a specialized balloon

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.