NCT06952374: SMARTMAC

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

Recruiting now NA Last updated 30 April 2025

What this trial tests

NA trial testing SmartWave Lithotripsy balloon in Mitral Annulus Calcification in 10 participants. Currently enrolling.

Timeline

8 March 2025

Primary endpoint
30 September 2026

31 March 2027

Quick facts

Lead sponsor	Prince of Wales Hospital, Shatin, Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	8 March 2025
Primary completion	30 September 2026
Estimated completion	31 March 2027
Sites	1 location across Hong Kong

Drugs / interventions tested

• SmartWave Lithotripsy balloon

Conditions studied

• Mitral Annulus Calcification — all drugs for Mitral Annulus Calcification →
• Rheumatic Heart Disease — all drugs for Rheumatic Heart Disease →

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Who can join

18 and older, any sex, with Mitral Annulus Calcification or Rheumatic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.