🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllPrince of Wales Hospital, Shatin, Hong Kong
NCT06952374 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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 alternativ

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • SmartWave Lithotripsy balloon
📍

Where

1 site
Prince of Wales Hospital
Shatin, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy