None listed
Conditions
Brief summary
This study is a prospective, multicentre, first-in-human study to evaluate the safety and effectiveness of the Shockwave Medical VTL II System with VTL II Catheter and Aortic Steerable Sheath to treat participants with symptomatic, severe calcified aortic stenosis. Eligible participants who meet all inclusion and exclusion criteria and provide informed consent will undergo transcatheter aortic valve lithotripsy (TAVL) 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 aortic valve tissue. Additional balloon aortic valvuloplasty and transcatheter aortic valve implantation may be performed at the operators 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, 12 months and 24 months post procedure. Study exit will occur between 12 and 24 months following the index procedure.
Interventions
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 hav
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.
Sponsors
Shockwave Medical, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed