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New treatment option for Mitral Annulus Calcification
Official title Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
ClinicalTrials.gov ID: NCT06952374
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Active infection with bacteremia
- Current participation in another investigational drug or device study
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, New Territories, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, New Territories, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.