None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of the Shockwave Medical Lithotplasty System for patients with severe calcified aortic stenosis, Who is it for? You may be eligible for this study if you are aged 18 or older and have severe calcified aortic stenosis. Study details All participants will receive TAVL treatment during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests such as CT scan, echocardiography (both transthoracic and oesophageal) , laboratory (blood tests) and undertake several questionnaires as a part of the clinical trial. It is hoped that this research will provide information into the non-surgical treatments of severe aortic stenosis thereby providing future non-surgery related options for the disease.
Interventions
Patients with severe calcified aortic stenosis fulfilling the inclusion / exclusion criteria will be treated once with the Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System. This system delivers lithotripsy energy waves via a proprietary catheter to calcified leaflets of the aortic valve in one treatment procedure. Up to 150 pulses (via up to 10 cycles of 15 pulses over 10 seconds per cycle) may be delivered (if required). The therapy is delivered in a single procedure adm
Patients with severe calcified aortic stenosis fulfilling the inclusion / exclusion criteria will be treated once with the Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System. This system delivers lithotripsy energy waves via a proprietary catheter to calcified leaflets of the aortic valve in one treatment procedure. Up to 150 pulses (via up to 10 cycles of 15 pulses over 10 seconds per cycle) may be delivered (if required). The therapy is delivered in a single procedure administered under general anaesthesia in a cardiac catheterisation laboratory by an interventional cardiologist. The procedure will take approximately 2 hours. Efficacy is measured intra-procedurally by changes in aortic valve function determined by echocardiography.
Sponsors
Shockwave Medical Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years 2. Senile degenerative aortic valve stenosis with the following assessed by echocardiogram performed within 60 days of the procedure: a. Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s, and b. An initial aortic valve area (AVA) of less than or equal to 0.8 cm2 or indexed effective orifice area (EOA) less than 0.5 cm2/m2 3. Symptomatic aortic valve stenosis with NYHA Class greater than Class II 4. Patient is able and willing to comply with all assessments in the study 5. Patient or patient’s legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form 6. Patient approved for inclusion by Physician Screening Committee
Exclusion criteria
1. Bicuspid aortic valve 2. Rheumatic valve disease 3. Aortic valve insufficiency greater than 2+ 4. Prior aortic valve surgery or endovascular procedure 5. Left ventricular ejection fraction (LVEF) less than 30% 6. Acute myocardial infarction within 30 days 7. Stroke or transient ischemic attack (TIA) within 12 months 8. Life expectancy less than one (1) year 9. High risk for stroke in the judgement of the investigator 10. History of endocarditis 11. Active infection 12. Need for emergency surgery for any reason 13. Known hypersensitivity or contraindication to anticoagulation, contrast or device components. 14. Severe vascular disease that would preclude safe access 15. Planned endovascular or surgical procedures within 30 days of index procedure with the exception of clinically-driven coronary revascularization 16. Patient is pregnant or nursing 17. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
Outcome results
None listed