Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001046392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
11/08/2026
Date registered
Help: Date registered
25/08/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
25/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Shockwave Medical Aortic First in Human Study utilising the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System for subjects with severe, calcified aortic stenosis
Scientific title
Prospective, Multicentre, First in Human (FIH) Study of the Shockwave Medical Valvular Transcatheter Lithotripsy II (VTL II) System with Valvular Transcatheter Lithotripsy II (VTL II) Catheter and Aortic Steerable Sheath for the Treatment of Symptomatic, Severe Calcified Aortic Stenosis
Additional trial identifiers [1] 318041 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Symptomatic, severe calcified aortic stenosis 343053 0
Condition category
Condition code
Cardiovascular 339150 339150 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is treatment with the transcatheter aortic valve lithotripsy (TAVL) using the Shockwave Medical VTL II System, a catheter-based device that delivers lithotripsy pulses to treat calcified aortic 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).
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 transfemoral approach under fluoroscopy and transoesophageal echocardiographic (TOE) guidance. A lithotripsy catheter is advanced across the aortic valve and delivers up to 200 pulses per patient at the discretion of the treating physician. Balloon aortic valvuloplasty and transcatheter aortic valve implantation may be performed following the 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.
Intervention code [1] 334925 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346390 0
A composite of all-cause mortality, stroke, and aortic valve-related re-hospitalisation
Timepoint [1] 346390 0
Within 30 days post TAVL procedure
Secondary outcome [1] 465630 0
A composite outcome defined as successful catheter delivery, delivery of lithotripsy energy and removal of catheter
Timepoint [1] 465630 0
During or immediately following the index procedure
Secondary outcome [2] 465631 0
A composite outcome defined as incidence of VARC-3 overt bleeding, Type 3 or 4
Timepoint [2] 465631 0
30 days post-procedure
Secondary outcome [3] 465632 0
A composite outcome defined as incidence of VARC-3 major vascular, access-related, or cardiac structural complications
Timepoint [3] 465632 0
30 day post-procedure
Secondary outcome [4] 465633 0
Incidence of VARC-3 acute kidney injury, Stage 3 or 4
Timepoint [4] 465633 0
30 days post-procedure
Secondary outcome [5] 465634 0
Incidence of new permanent pacemaker implantation
Timepoint [5] 465634 0
30 days post-procedure
Secondary outcome [6] 465635 0
Incidence of VARC-3 all-cause mortality
Timepoint [6] 465635 0
6-, 12- and 24-months post-procedure
Secondary outcome [7] 465636 0
Incidence of VARC-3 aortic valve-related re-hospitalisation
Timepoint [7] 465636 0
6-, 12- and 24-months post-procedure
Secondary outcome [8] 465637 0
A composite outcome defined as a change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Timepoint [8] 465637 0
Pre-procedure (baseline), 30 days, 6-, 12- and 24-months post-procedure
Secondary outcome [9] 465989 0
A composite outcome of post-TAVL procedural TOE haemodynamics compared to pre-TAVL haeomdynamics
Timepoint [9] 465989 0
Pre-procedure (baseline) and following the index procedure
Secondary outcome [10] 466064 0
A composite outcome of Transthoracic echocardiogram (TTE) haemodynamics
Timepoint [10] 466064 0
Pre-procedure (baseline) and following the index procedure

Eligibility
Key inclusion criteria
Subjects re 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
2. Participant diagnosed with severe aortic stenosis defined as Aortic Valve Area less than or equal to 1.0cm squared, mean pressure gradient greater than or equal to 40mmHg, or doppler velocity index less than or equal to 0.25
3. Symptomatic calcific aortic valve stenosis with New York Heart Association Class greater than or equal to II
4. Native aortic valve
5. Participant is able and willing to comply with all assessments in the study
6. Participant has been informed of the nature of the study, agrees to participate and has signed the approved consent form
7. Participant eligibility approved by Physician Screening Committee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Participant 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 posttreatment, 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. Bicuspid Aortic Valve
4. Rheumatic heart disease
5. Aortic valve regurgitation greater than 1+ (Mild)
6. Prior aortic valve intervention, surgery or replacement at any timepoint, cardiovascular surgery, or carotid surgery within 90 days prior to the index procedure
7. Left ventricular ejection fraction less than 30 percent
8. Myocardial infarction [defined as Fourth Universal Definition of MI] within 30 days prior to the index procedure
9. History of significant arrhythmia requiring hospitalization within 30 days prior to the index procedure
10. Stroke or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the index procedure
11. Participant has acute or chronic renal disease with eGFR less than 30 ml/min/1.73m squared (using CKD-EPI formula) or is on any form of dialysis
12. History of or active endocarditis
13. Active infection
14. Leukopenia (WBC less than 2000 cells/mL), anaemia (Hgb less than 9 g/dL), thrombocytopenia (platelet less than 100,000 cells/mL), history of bleeding diathesis or coagulopathy, hypercoagulable states, or participant refuses blood/blood product transfusion
15. Need for emergency surgery for any reason within 30 days prior to index procedure
16. Inability to tolerate, or any condition precluding treatment with anticoagulant therapy (e.g. active bleeding)
17. Planned endovascular or surgical procedures within 30 days prior to or following the index procedure
18. Untreated, clinically significant CAD or PCI within 30 days prior to the index procedure
19. Need for mitral, tricuspid, or pulmonary valve intervention within 12 months following the index procedure
20. Evidence of intracardiac mass, thrombus, or vegetation
21. Participant is contraindicated for transoesophageal echocardiography (TOE) or aortic valve anatomy not fully evaluable by TTE and TOE.
22. Participants with hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy, or infiltrative cardiomyopathy
23. Participants with refractory heart failure (Stage D) requiring advanced intervention (LVAD, transplant)
24. Hospitalisation for heart failure within 30 days prior to the index procedure
25. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the index procedure
26. Participant is pregnant or breastfeeding
27. Participant is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
28. History of COVID-19 with sequelae that could confound endpoint assessments
29. Any participants considered to be vulnerable (ISO 14155)
30. Participant’s anatomy is unsuitable for transfemoral access or TAVI deployment
31. High mortality and morbidity risk score greater than 8 percent by Society of Thoracic Surgeons (STS) risk calculator

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Per ISO 14155, 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 45, 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29924 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 46287 0
3168 - Clayton
Recruitment outside Australia
Country [1] 28387 0
Georgia
State/province [1] 28387 0
Country [2] 28388 0
New Zealand
State/province [2] 28388 0

Funding & Sponsors
Funding source category [1] 322599 0
Commercial sector/Industry
Name [1] 322599 0
Shockwave Medical, Inc.
Country [1] 322599 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Shockwave Medical, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 325519 0
Commercial sector/Industry
Name [1] 325519 0
Australian Healthcare Solutions Pty Ltd
Address [1] 325519 0
Country [1] 325519 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321065 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 321065 0
Ethics committee country [1] 321065 0
Australia
Date submitted for ethics approval [1] 321065 0
22/04/2026
Approval date [1] 321065 0
13/07/2026
Ethics approval number [1] 321065 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152546 0
A/Prof Robert Gooley
Address 152546 0
Victorian Heart Hospital, 631 Blackburn Road, Clayton VIC 3168
Country 152546 0
Australia
Phone 152546 0
+61 3 7511 1268
Fax 152546 0
Email 152546 0
[email protected]
Contact person for public queries
Name 152547 0
Matthew Godden
Address 152547 0
Australian Healthcare Solutions Pty Ltd, Suite 207, 19 Thompson Street, Abbotsford, Vic 3067
Country 152547 0
Australia
Phone 152547 0
+61 400 007 127
Fax 152547 0
Email 152547 0
[email protected]
Contact person for scientific queries
Name 152548 0
Matthew Godden
Address 152548 0
Australian Healthcare Solutions Pty Ltd, Suite 207, 19 Thompson Street, Abbotsford, Vic 3067
Country 152548 0
Australia
Phone 152548 0
+61 400 007 127
Fax 152548 0
Email 152548 0
[email protected]

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.