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

NARecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 8, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2027

Conditions
Mitral Annulus CalcificationRheumatic Heart Disease
Interventions
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.

Trial Locations (1)

999077

RECRUITING

Prince of Wales Hospital, Shatin

All Listed Sponsors
collaborator

Peijia Medical Technology (Suzhou) Co., Ltd.

INDUSTRY

lead

Prince of Wales Hospital, Shatin, Hong Kong

OTHER