Mitral Annulus CalcificationSMARTMACNCT06952374
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
A study testing SmartWave Lithotripsy balloon in people with Mitral Annulus Calcification and Rheumatic Heart Disease, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Annulus Calcification, Rheumatic Heart Disease
- What is being tested?
- SmartWave Lithotripsy balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Mar 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, New Territories, 999077
Kent So, MBChB, 85235051518, kentso@cuhk.edu.hk
Daniel Xu, Nursing officer, 85235051518, danielxu@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Being tested
- SmartWave Lithotripsy balloon
- Keywords
- Mitral valve stenosis
- Medical subject headings
- Rheumatic Heart Disease, Mitral Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartWave Lithotripsy balloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SmartWave | Experimental | Not described Receives: Device: SmartWave Lithotripsy balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in mitral valve area
Immediate and sustained improvement in mitral valve area (MVA >1.5cm^2) without significant worsening of MR (> moderate)
Measured: Post-OP 6 and 12 month
Absence of peri-procedural complication
Absence of peri-procedural complication (death, stroke, myocardial infarction, cardiac tamponade, conversion to open heart) defined according to the Mitral Valve Academic Research Consortium
Measured: At and peri-procedure
Secondary outcomes (8)
Hemodynamic changes
Invasive haemodyanmic changes after each lithotripsy cycle
Measured: Intra-operation
Mitral valve calcification level
Baseline and post-procedural mitral valve calcium distribution and volume determined by computed tomography
Measured: Baseline and post-procedure up to 1 year
Symptom status change (New York Heart Aassociation functional class)
Symptom status change assessed by New York Heart Aassociation functional class
Measured: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Symptom status change (By Kansas City Cardiomyopathy Questionnaire-12)
Symptom status change assessed by Kansas City Cardiomyopathy Questionnaire-12
Measured: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Debris histology
Sentinel captured debris will be collected and sent for histology analysis to look for signs of tissue damage or calcification break off.
Measured: peri-operation
NTproBNP
Change of NTproBNP
Measured: baseline, post-operation, Post-OP 1, 3, 6, 12 month
Lung Fluid
Change in lung fluid percentage
Measured: baseline, Post-OP 1, 3, 6, 12 month
Major Adverse Cardiac Event
6 month and 12 month clinical event (death, heart failure hospitalization, stroke, myocardial infarction, mitral valve reintervention)
Measured: 6 month and 12 month post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start8 Mar 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Mitral Annulus CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Kent So, MbChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952374
- Sponsor's protocol ID
- 2024.362
- Acronym
- SMARTMAC
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.
PubMed 26184623Giustino G, Fang JX, Villablanca PA, Wang DD, Sturla N, Lee JC, O'Neill BP, Frisoli T, O'Neill WW, Engel-Gonzalez P. Intravascular Lithotripsy-Facilitated Balloon Valvuloplasty for Severely Calcified Mitral Valve Stenosis. JACC Cardiovasc Interv. 2024 Jan 22;17(2):326-327. doi: 10.1016/j.jcin.2023.10.015. Epub 2023 Dec 20. No abstract available.
PubMed 38127026Sharma A, Kelly R, Mbai M, Chandrashekhar Y, Bertog S. Transcatheter Mitral Valve Lithotripsy as a Pretreatment to Percutaneous Balloon Mitral Valvuloplasty for Heavily Calcified Rheumatic Mitral Stenosis. Circ Cardiovasc Interv. 2020 Jul;13(7):e009357. doi: 10.1161/CIRCINTERVENTIONS.120.009357. Epub 2020 Jul 17. No abstract available.
PubMed 32674681Eng MH, Villablanca P, Wang DD, Frisoli T, Lee J, O'Neill WW. Lithotripsy-Facilitated Mitral Balloon Valvuloplasty for Senile Degenerative Mitral Valve Stenosis. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e133-e134. doi: 10.1016/j.jcin.2019.05.026. Epub 2019 Jul 17. No abstract available.
PubMed 31326427Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
PubMed 34167675Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21.
PubMed 38385926Kereiakes DJ, Hill JM, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Arteries: 2-Year Results-Disrupt CAD III Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2472-2474. doi: 10.1016/j.jcin.2023.07.010. Epub 2023 Sep 6. No abstract available.
PubMed 37676225Ali ZA, Kereiakes D, Hill J, Saito S, Di Mario C, Honton B, Gonzalo N, Riley R, Maehara A, Matsumura M, Stone GW, Shlofmitz R. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules. JACC Cardiovasc Interv. 2023 May 8;16(9):1122-1124. doi: 10.1016/j.jcin.2023.02.015. Epub 2023 Apr 5. No abstract available.
PubMed 37029020Maisano F, Taramasso M. Mitral valve-in-valve, valve-in-ring, and valve-in-MAC: the Good, the Bad, and the Ugly. Eur Heart J. 2019 Feb 1;40(5):452-455. doi: 10.1093/eurheartj/ehy725. No abstract available.
PubMed 30476035Guerrero ME, Eleid MF, Wang DD, Pursnani A, Kodali SK, George I, Palacios I, Russell H, Makkar RR, Kar S, Satler LF, Rajagopal V, Dangas G, Tang GHL, McCabe JM, Whisenant BK, Fang K, Balan P, Smalling R, Kaptzan T, Lewis B, Douglas PS, Hahn RT, Thaden J, Oh JK, Leon M, O'Neill W, Rihal C. 5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results. JACC Cardiovasc Interv. 2023 Sep 25;16(18):2211-2227. doi: 10.1016/j.jcin.2023.06.041.
PubMed 37758379Guerrero M, Wang DD, Pursnani A, Eleid M, Khalique O, Urena M, Salinger M, Kodali S, Kaptzan T, Lewis B, Kato N, Cajigas HM, Wendler O, Holzhey D, Pershad A, Witzke C, Alnasser S, Tang GHL, Grubb K, Reisman M, Blanke P, Leipsic J, Williamson E, Pellikka PA, Pislaru S, Crestanello J, Himbert D, Vahanian A, Webb J, Hahn RT, Leon M, George I, Bapat V, O'Neill W, Rihal C. A Cardiac Computed Tomography-Based Score to Categorize Mitral Annular Calcification Severity and Predict Valve Embolization. JACC Cardiovasc Imaging. 2020 Sep;13(9):1945-1957. doi: 10.1016/j.jcmg.2020.03.013. Epub 2020 May 13.
PubMed 32417332Chehab O, Roberts-Thomson R, Bivona A, Gill H, Patterson T, Pursnani A, Grigoryan K, Vargas B, Bokhary U, Blauth C, Lucchese G, Bapat V, Guerrero M, Redwood S, Prendergast B, Rajani R. Management of Patients With Severe Mitral Annular Calcification: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Aug 16;80(7):722-738. doi: 10.1016/j.jacc.2022.06.009.
PubMed 35953138Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988 Oct;60(4):299-308. doi: 10.1136/hrt.60.4.299.
PubMed 3190958Iung B, Nicoud-Houel A, Fondard O, Hafid Akoudad, Haghighat T, Brochet E, Garbarz E, Cormier B, Baron G, Luxereau P, Vahanian A. Temporal trends in percutaneous mitral commissurotomy over a 15-year period. Eur Heart J. 2004 Apr;25(8):701-7. doi: 10.1016/j.ehj.2004.02.026.
PubMed 15084376Writing Committee Members; Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021 Feb 2;77(4):e25-e197. doi: 10.1016/j.jacc.2020.11.018. Epub 2020 Dec 17. No abstract available.
PubMed 33342586
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Lithotripsy Using the SMARTWAVE Balloon for Severe Mitral Annular or Valvular Calcification (SMART-MAC): First in Human Study
- ClinicalTrials.gov ID
- NCT06952374
- Acronym / sponsor ID
- SMARTMAC / 2024.362
- Keywords
- Mitral valve stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Collaborators
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Study start
- 8 Mar 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartWave | Experimental | Device: SmartWave Lithotripsy balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartWave Lithotripsy balloonntravascular 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. | Device | SmartWave |
Primary outcome
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)
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
8 secondary outcomes
Hemodynamic changes
Time frame: Intra-operation
Mitral valve calcification level
Time frame: 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 (By Kansas City Cardiomyopathy Questionnaire-12)
Time frame: Baseline,Post-OP 1 month, 3 month, 6 month, 12 month
Debris histology
Time frame: peri-operation
NTproBNP
Time frame: baseline, post-operation, Post-OP 1, 3, 6, 12 month
Lung Fluid
Time frame: baseline, Post-OP 1, 3, 6, 12 month
Major Adverse Cardiac Event
Time frame: 6 month and 12 month post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 26184623Stone GW, Adams DH, Abraham WT, Kappetein AP, Genereux P, Vranckx P, Mehran R, Kuck KH, Leon MB, Piazza N, Head SJ, Filippatos G, Vahanian AS; Mitral Valve Academic Research Consortium (MVARC). Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol. 2015 Jul 21;66(3):308-321. doi: 10.1016/j.jacc.2015.05.049.
- Background: PubMed 38127026Giustino G, Fang JX, Villablanca PA, Wang DD, Sturla N, Lee JC, O'Neill BP, Frisoli T, O'Neill WW, Engel-Gonzalez P. Intravascular Lithotripsy-Facilitated Balloon Valvuloplasty for Severely Calcified Mitral Valve Stenosis. JACC Cardiovasc Interv. 2024 Jan 22;17(2):326-327. doi: 10.1016/j.jcin.2023.10.015. Epub 2023 Dec 20. No abstract available.
- Background: PubMed 32674681Sharma A, Kelly R, Mbai M, Chandrashekhar Y, Bertog S. Transcatheter Mitral Valve Lithotripsy as a Pretreatment to Percutaneous Balloon Mitral Valvuloplasty for Heavily Calcified Rheumatic Mitral Stenosis. Circ Cardiovasc Interv. 2020 Jul;13(7):e009357. doi: 10.1161/CIRCINTERVENTIONS.120.009357. Epub 2020 Jul 17. No abstract available.
- Background: PubMed 31326427Eng MH, Villablanca P, Wang DD, Frisoli T, Lee J, O'Neill WW. Lithotripsy-Facilitated Mitral Balloon Valvuloplasty for Senile Degenerative Mitral Valve Stenosis. JACC Cardiovasc Interv. 2019 Aug 12;12(15):e133-e134. doi: 10.1016/j.jcin.2019.05.026. Epub 2019 Jul 17. No abstract available.
- Background: PubMed 34167675Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
- Background: PubMed 38385926Rodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21.
- Background: PubMed 37676225Kereiakes DJ, Hill JM, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Arteries: 2-Year Results-Disrupt CAD III Study. JACC Cardiovasc Interv. 2023 Oct 9;16(19):2472-2474. doi: 10.1016/j.jcin.2023.07.010. Epub 2023 Sep 6. No abstract available.
- Background: PubMed 37029020Ali ZA, Kereiakes D, Hill J, Saito S, Di Mario C, Honton B, Gonzalo N, Riley R, Maehara A, Matsumura M, Stone GW, Shlofmitz R. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Calcified Nodules. JACC Cardiovasc Interv. 2023 May 8;16(9):1122-1124. doi: 10.1016/j.jcin.2023.02.015. Epub 2023 Apr 5. No abstract available.
- Background: PubMed 30476035Maisano F, Taramasso M. Mitral valve-in-valve, valve-in-ring, and valve-in-MAC: the Good, the Bad, and the Ugly. Eur Heart J. 2019 Feb 1;40(5):452-455. doi: 10.1093/eurheartj/ehy725. No abstract available.
- Background: PubMed 37758379Guerrero ME, Eleid MF, Wang DD, Pursnani A, Kodali SK, George I, Palacios I, Russell H, Makkar RR, Kar S, Satler LF, Rajagopal V, Dangas G, Tang GHL, McCabe JM, Whisenant BK, Fang K, Balan P, Smalling R, Kaptzan T, Lewis B, Douglas PS, Hahn RT, Thaden J, Oh JK, Leon M, O'Neill W, Rihal C. 5-Year Prospective Evaluation of Mitral Valve-in-Valve, Valve-in-Ring, and Valve-in-MAC Outcomes: MITRAL Trial Final Results. JACC Cardiovasc Interv. 2023 Sep 25;16(18):2211-2227. doi: 10.1016/j.jcin.2023.06.041.
- Background: PubMed 32417332Guerrero M, Wang DD, Pursnani A, Eleid M, Khalique O, Urena M, Salinger M, Kodali S, Kaptzan T, Lewis B, Kato N, Cajigas HM, Wendler O, Holzhey D, Pershad A, Witzke C, Alnasser S, Tang GHL, Grubb K, Reisman M, Blanke P, Leipsic J, Williamson E, Pellikka PA, Pislaru S, Crestanello J, Himbert D, Vahanian A, Webb J, Hahn RT, Leon M, George I, Bapat V, O'Neill W, Rihal C. A Cardiac Computed Tomography-Based Score to Categorize Mitral Annular Calcification Severity and Predict Valve Embolization. JACC Cardiovasc Imaging. 2020 Sep;13(9):1945-1957. doi: 10.1016/j.jcmg.2020.03.013. Epub 2020 May 13.
- Background: PubMed 35953138Chehab O, Roberts-Thomson R, Bivona A, Gill H, Patterson T, Pursnani A, Grigoryan K, Vargas B, Bokhary U, Blauth C, Lucchese G, Bapat V, Guerrero M, Redwood S, Prendergast B, Rajani R. Management of Patients With Severe Mitral Annular Calcification: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Aug 16;80(7):722-738. doi: 10.1016/j.jacc.2022.06.009.
- Individual participant dataSharing planned: Undecided
Related trials for Mitral Annulus Calcification
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kent So, MbChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartWave Lithotripsy balloon in people with Mitral Annulus Calcification and Rheumatic Heart Disease, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Xu, Nursing Officer (85235051518, danielxu@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in mitral valve area (time frame: Post-OP 6 and 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952374, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.