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Trial registered on ANZCTR
Registration number
ACTRN12626000799358
Ethics application status
Approved
Date submitted
11/06/2026
Date registered
3/07/2026
Date last updated
3/07/2026
Date data sharing statement initially provided
3/07/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Shockwave Medical Mitral First in Human Study utilising the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System for subjects with severe, calcific mitral stenosis
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Scientific title
Prospective, Multicentre, First in Human (FIH) Study of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System for the Treatment of Symptomatic Severe Calcified Mitral Stenosis.
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Additional trial identifiers [1]
317527
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Symptomatic, severe calcified mitral stenosis
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Condition category
Condition code
Cardiovascular
338382
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The intervention is treatment with the transcatheter mitral valve lithotripsy (TMVL) using the Shockwave Medical VTL II System, a catheter-based device that delivers lithotripsy pulses to treat calcified mitral valve tissue. The procedure is performed by appropriately trained interventional/ structural heart cardiologists (with involvement of a multidisciplinary team including cardiac imaging specialists, cardiothoracic surgeons, and anaesthetists). Operator training includes prior specialist experience in structural heart interventions, preclinical in-person laboratory and simulation training relevant to the device and procedure, and study-specific training. This study-specific training was delivered by Shockwave Medical as a 1-hour online workshop for all delegated site personnel and covered device and procedure aspects. Representatives from Shockwave Medical who have been trained on the study devices will attend all index procedures to provide guidance and technical support.
The intervention is delivered via a percutaneous transseptal approach under fluoroscopic and transoesophageal echocardiographic (TOE) guidance. A lithotripsy catheter is advanced across the mitral valve and delivers up to 200 pulses per patient. Balloon mitral valvuloplasty may be performed following VTL II therapy at the operator's discretion.
The intervention is delivered as a single procedure of approximately 2 hours during the index hospitalisation in a cardiac catheterisation laboratory or hybrid suite.
Adherence is ensured through protocol-defined procedures, trained operators, and continuous intraprocedural monitoring (including imaging and haemodynamic assessment), with all device use, procedural steps, and adverse events recorded.
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Intervention code [1]
334324
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Treatment: Devices
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Description of the comparator or control
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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A composite of all-cause mortality, stroke, and heart failure related re-hospitalisation
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Assessment method [1]
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By monitoring adverse events and serious adverse events, as reported by subjects and documented in the participant's medical history. Adverse events include; untoward medical occurrence, unintended disease or injury, or untoward clinical signs. Clinical outcomes will then be evaluated by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [1]
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Within 30 days post TMVL procedure
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Secondary outcome [1]
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A composite outcome defined as freedom from attempted or successful rescue transcatheter intervention, Transcatheter Mitral Valve Replacement (TMVR) or Transcatheter Edge-To-Edge Repair (TEER), or surgical intervention of the mitral valve during the index procedure
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Assessment method [1]
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Observation and monitoring of whether TMVR, TEER or surgical mitral valve intervention took place
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Timepoint [1]
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During or immediately following the index procedure
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Secondary outcome [2]
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Incidence of VARC-3 (Valve Academic Research Consortium) all-cause mortality
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Assessment method [2]
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Utilisation of the VARC-3 criteria to assess all-cause mortality by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [2]
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6- and 12-months post-procedure
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Secondary outcome [3]
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Incidence of VARC-3 stroke
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Assessment method [3]
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Utilisation of the VARC-3 criteria to assess stroke by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [3]
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6- and 12-months post procedure
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Secondary outcome [4]
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Incidence of VARC-3 heart failure related hospitalisation
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Assessment method [4]
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Utilisation of the VARC-3 criteria to assess heart failure related hospitalisation by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [4]
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6- and 12-months post procedure
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Secondary outcome [5]
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A composite outcome defined as incidence of VARC-3 overt bleeding requiring transfusion, Type 3 or 4
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Assessment method [5]
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Utilisation of the VARC-3 criteria to assess overt bleeding requiring transfusion, Type 3 or 4 by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [5]
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30 days post-procedure
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Secondary outcome [6]
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A composite outcome defined as incidence of VARC-3 major vascular, access-related, or cardiac structural complications
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Assessment method [6]
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Utilisation of the VARC-3 criteria to assess major vascular, access-related, or cardiac structural complications by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [6]
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30 days post-procedure
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Secondary outcome [7]
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A composite outcome defined as incidence of VARC-3 acute kidney injury, Stage 3 or 4
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Assessment method [7]
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Utilisation of the VARC-3 criteria to assess acute kidney injury, Stage 3 or 4 by the Clinical Events Committee, using data collected form hospital medical records, procedural records, and follow-up documentation.
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Timepoint [7]
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30 days post-procedure
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Secondary outcome [8]
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A composite outcome of device success defined as successful catheter delivery, delivery of lithotripsy energy and removal of catheter
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Assessment method [8]
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By assessing delivery of the catheter, lithotripsy pulses, and removal of the catheter through direct observation and imaging throughout the procedure.
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Timepoint [8]
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During the index procedure
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Secondary outcome [9]
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Kansas City Cardiomyopathy Questionnaire (KCCQ) score
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Assessment method [9]
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KCCQ score compared to baseline score
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Timepoint [9]
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30 days, 6- and 12-months post index procedure
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Secondary outcome [10]
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6-Minute Walk Test (6MWT) score
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Assessment method [10]
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6MWT score compared to baseline score
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Timepoint [10]
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30 days, 6- and 12-months post index procedure
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Secondary outcome [11]
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Post-TMVL and Post-BMV procedural transoesophageal echocardiogram (TOE) haemodynamics
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Assessment method [11]
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Utilisation of TOE to assess the following compared to pre-TMVL; Mean mitral valve pressure gradient Mitral valve area Mitral regurgitation grade Change in native leaflet mobility
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Timepoint [11]
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During and at completion of index procedure
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Secondary outcome [12]
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Transthoracic echocardiogram (TTE) haemodynamics
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Assessment method [12]
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Utilisation of TTE to assess the following compared to baseline; Mean mitral valve pressure gradient Mitral valve area Mitral regurgitation
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Timepoint [12]
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Discharge, 30 days, 6- and 12-months post index procedure
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Eligibility
Key inclusion criteria
Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the study:
1. Age is greater than or equal to 18 years
2. Subjects diagnosed with symptomatic severe, calcified mitral stenosis defined as Mitral Valve Area (MVA) is less than or equal to 1.5cm squared, Mean Gradient greater than or equal to 8mmHg or mitral valve diastolic pressure half time less than or equal to 150ms
3. Primary investigator and heart team agrees that the subject is indicated for TMVL treatment
4. Symptomatic calcified mitral valve stenosis with New York Heart Association (NYHA) class greater than or equal to 2
5. Native mitral valve
6. Subject is able and willing to comply with all assessments in the study
7. Subject has been informed of the nature of the study, agrees to participate and has signed the approved consent form
8. Subject eligibility approved by Physician Screening Committee
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Subjects who meet any of the following exclusion criteria may not be enrolled in the study:
1. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment, or impact the scientific soundness of the clinical investigation result
2. Co-morbid conditions that, in the opinion of the investigator, limit life expectancy to less than 1 year
3. Rheumatic heart disease
4. Mitral valve regurgitation greater than 1 plus (Mild)
5. Prior mitral valve intervention or surgery at any timepoint, cardiovascular surgery, or carotid surgery within 90 days prior to the index procedure
6. Severe Chronic Obstructive Pulmonary Disease (COPD) defined as forced expiratory volume (FEV1) of less than 750cc, continuous home oxygen, or chronic systemic outpatient steroid use
7. Severe pulmonary hypertension with a fixed pulmonary artery systolic pressure (PASP) greater than 70mmHg
8. Inferior Vena Cava (IVC) filter that would interfere with delivery of catheter
9. Left ventricular ejection fraction (LVEF) less than 30 percent
10. Myocardial infarction within 30 days [defines as Fourth Universal Definition of MI] prior to the index procedure
11. History of significant arrhythmia requiring hospitalisation within 30 days prior to the index procedure
12. Stroke or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the index procedure
13. Subject has acute or chronic renal disease with eGRF less than 30ml/min/1.73m squared (using CKD-EPI formula) or is on any form of dialysis
14. History of or active endocarditis
15. Active infection
16. Liver failure (Child-Pugh-C)
17. Need for emergency surgery of any reason within 30 days prior to the index procedure
18. Leukopenia (WBC less than 2000 cells/mL), anaemia (Hgb less than 9g/dL), thrombocytopenia (platelet less than 100,000 cells/mL), history of bleeding diathesis or coagulopathy, hypercoagulable states, or subject refuses blood/blood product transfusion
19. Inability to tolerate, or precluding condition, treatment with anticoagulant therapy
20. Hospitalisation for heart failure within 30 days prior to the index procedure
21. Planned endovascular or surgical procedures within 30 days prior to or following the index procedure
22. Untreated, clinically significant CAD or PCI within 30 days prior to the index procedure
23. Need for aortic, tricuspid, or pulmonary valve intervention within 123 months following index procedure
24. Severe Tricuspid Regurgitation (TR) greater than or equal to 4 plus or severe aortic stenosis
25. evidence of intracardiac mass, thrombus, or vegetation
26. Subject is contraindicated for Transoesophageal echocardiography (TOE) or mitral valve anatomy not fully evaluable by TTE and TOE
27. Subjects with hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy, or infiltrative cardiomyopathy
28. Subjects with refractory heart failure (Stage D) requiring advanced interventi9o0n (LVAD, transplant)
29. Haemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the index procedure
30. Subject is pregnant or breastfeeding
31. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
32. Active COVID-19 or previously diagnosed COVID-19 with sequelae that could confound endpoint assessments
33. Any subject considered to be vulnerable (ISO 14155)
34. Subject's anatomy is unsuitable for transfemoral venous access or transseptal puncture
35. High mortality and morbidity risk score greater than 8 percent by Society of Thoracic Surgeons (STS) risk calculator
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Per ISO 14155:2020, the study is considered to be an exploratory clinical investigation that does not have pre-specified primary hypothesis. For feasibility studies, sample sizes between 12 and 50 have been recommended. The sample size for this study, up to 20, is in keeping with these published recommendations.
The number of subjects to be enrolled in this study will not equate to the ability to assess statistical significance.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2026
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Victorian Heart Hospital - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
28199
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Georgia
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State/province [1]
28199
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Country [2]
28200
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New Zealand
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State/province [2]
28200
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Shockwave Medical, Inc.
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Shockwave Medical, Inc.
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Address
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Australian Healthcare Solutions Pty Ltd
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Address [1]
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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07/01/2026
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Approval date [1]
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28/04/2026
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Ethics approval number [1]
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Summary
Brief summary
This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System in subjects with symptomatic, severe calcified mitral stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo a transcatheter mitral valve lithotripsy (TMVL) procedure using the VTL II System. The procedure is performed via a trans-vascular approach in a catheterisation laboratory or a hybrid suite, where lithotripsy (soundwaves) pulses are delivered to modify calcified mitral valve tissue. Additional balloon mitral valvuloplasty may be performed at the operator's discretion. Participants will receive standard post-procedural care and be followed during hospitalisation and at discharge. Follow-up assessments will occur at discharge, 30 days, 6 months, and 12 months post procedure. Study exit occurs at 12 months following the index procedure.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Robert Gooley
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Address
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Victorian Heart Hospital, 631 Blackburn Road, Clayton VIC 3168
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Country
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Australia
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Phone
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+61 3 7511 1268
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Matthew Godden
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Address
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Australian Healthcare Solutions Pty Ltd, Suite 207, 19 Thompson Street, Abbotsford, 3067
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Country
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Australia
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Phone
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+61 400 007 127
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Matthew Godden
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Address
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Australian Healthcare Solutions Pty Ltd, Suite 207, 19 Thompson Street, Abbotsford, 3067
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Country
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Australia
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Phone
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+61 400 007 127
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF