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 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.
Interventions
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 ex
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.
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 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
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
Outcome results
None listed