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

Launched by PRINCE OF WALES HOSPITAL, SHATIN, HONG KONG · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with severe mitral stenosis, a heart condition where the mitral valve doesn't open properly. This can be due to hardening or calcification of the valve, which makes it difficult for blood to flow and can lead to serious complications. The study is testing a special balloon called the SmartWave lithotripsy balloon, designed to break up the hard calcium deposits in the mitral valve, making it easier to treat with other procedures. This trial aims to find out if the SmartWave balloon can help improve valve function and make other treatments safer for patients who have severe calcification.

To be eligible for this trial, participants must be over 18 years old, able to give consent, and have severe symptoms of mitral stenosis along with significant calcification of the valve. However, those with certain heart conditions or active infections cannot participate. If someone joins the trial, they can expect to undergo a procedure with the SmartWave balloon, which may help improve their heart condition. This study is currently recruiting participants, and it represents a potential new option for those struggling with this challenging heart disease.

Gender

ALL

Eligibility 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