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

April 23, 2025 updated by: Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong

Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study

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 alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.

Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.

SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 alternative in treating these patients. However, valve-in-MAC is not always feasible and still carries operative and 30-day mortality.

Intravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer. However, the off-label use of multiple peripheral lithotripsy balloons in mitral valve is technically complicated.

SmartWave balloon was specifically designed lithotripsy balloon for calcified aortic stenosis. This first-in-human study aims to apply the SmartWave lithotripsy balloon in treating calcified mitral stenosis due to MAC or severely calcified rheumatic mitral valve.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, 999077
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chak Yu So, Clinical assistant professor
        • Sub-Investigator:
          • Hei Tung Chan, Resident
        • Sub-Investigator:
          • Fuk Kei Fong, Resident
        • Sub-Investigator:
          • Hoi Ting Kwok, Resident
        • Sub-Investigator:
          • Ling Na Wong, Resident
        • Sub-Investigator:
          • Ka Ho Kam, Consultant
        • Principal Investigator:
          • Pui Wai Lee, Professor
        • Sub-Investigator:
          • Ka Lung Chui, Consultant
        • Sub-Investigator:
          • Ho Fung Mok, Resident
        • Sub-Investigator:
          • Yan Kit Ho, Associate consultant
        • Sub-Investigator:
          • Hung Leung Wong, Professor
        • Sub-Investigator:
          • Simon Chow, Associate consultant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SmartWave
Device: SmartWave Lithotripsy balloon
ntravascular lithotripsy is an approved adjunct interventional therapy in treating calcified lesions to facilitate stenotic lesion opening in peripheral vascular disease and coronary artery disease. The off-label use of current peripheral lithotripsy balloon in mitral valve as a compassionate treatment or as an adjunct treatment before mitral balloon valvuloplasty and transcatheter mitral valve replacement has been reported with success . A possible mechanism is that lithotripsy preferentially impacts hard tissue, disrupts calcium, and leaves soft tissue undisturbed, improving valve pliability, preventing leaflet damage, and making subsequent valvuloplasty safer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in mitral valve area
Time Frame: Post-OP 6 and 12 month
Immediate and sustained improvement in mitral valve area (MVA >1.5cm^2) without significant worsening of MR (> moderate)
Post-OP 6 and 12 month
Absence of peri-procedural complication
Time Frame: At and peri-procedure
Absence of peri-procedural complication (death, stroke, myocardial infarction, cardiac tamponade, conversion to open heart) defined according to the Mitral Valve Academic Research Consortium
At and peri-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes
Time Frame: Intra-operation
Invasive haemodyanmic changes after each lithotripsy cycle
Intra-operation
Mitral valve calcification level
Time Frame: Baseline and post-procedure up to 1 year
Baseline and post-procedural mitral valve calcium distribution and volume determined by computed tomography
Baseline and post-procedure up to 1 year
Symptom status change (New York Heart Aassociation functional class)
Time Frame: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Symptom status change assessed by New York Heart Aassociation functional class
Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Symptom status change (By Kansas City Cardiomyopathy Questionnaire-12)
Time Frame: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Symptom status change assessed by Kansas City Cardiomyopathy Questionnaire-12
Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Debris histology
Time Frame: peri-operation
Sentinel captured debris will be collected and sent for histology analysis to look for signs of tissue damage or calcification break off.
peri-operation
NTproBNP
Time Frame: baseline, post-operation, Post-OP 1, 3, 6, 12 month
Change of NTproBNP
baseline, post-operation, Post-OP 1, 3, 6, 12 month
Lung Fluid
Time Frame: baseline, Post-OP 1, 3, 6, 12 month
Change in lung fluid percentage
baseline, Post-OP 1, 3, 6, 12 month
Major Adverse Cardiac Event
Time Frame: 6 month and 12 month post-operation
6 month and 12 month clinical event (death, heart failure hospitalization, stroke, myocardial infarction, mitral valve reintervention)
6 month and 12 month post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Collaborators

Peijia Medical Technology (Suzhou) Co., Ltd.

Investigators

  • Principal Investigator: Kent So, MbChB, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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