A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)

Ki vehet részt

• ≥ 18 years of age
• Symptomatic, degenerative, tricuspid, severe aortic stenosis
• TTE derived aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed effective orifice area (EOAi) ≤ 0.6 cm2 /m2)
• TTE derived AV mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or Doppler Velocity Index (DVI) ≤ 0.25
• CT TAVI deemed of good quality (as per standard operating procedure) within past 6 months
• TTE of good quality within past 6 months as defined by:; Doppler signal across the aortic valve and LVOT is a clear and artifact-free waveform; Correct alignment to the blood flow direction to ensure accurate velocity measurements; Following measurements available; Continuous-wave Doppler (CW) across the aortic valve; AV Vmax, AV Vmean, AV peak gradient (MaxPG), AV mean gradient (meanPG), AV Velocity-Time integral (VTI), heart rate (HR); Pulse-wave Doppler (PW) across the LVOT; LVOT Vmax, LVOT Vmean, LVOT MaxPG, LVOT meanPG, LVOT VTI; 2D LVOT diameter in plax view
• In sinus rhythm at time of any TTE or CT scans
• Undergone a technically successful elective TAVI as defined by the operator using a Edwards Sapien 3 Ultra (20, 23, 26 or 29 mm):; Position and height as planned; Trivial aortic regurgitation; No vascular or other complications prolonging discharge

Ki nem vehet részt

• Previous TAVI or Aortic Valve Replacement (AVR)
• Evidence of an acute myocardial infarction within 30 days prior to index procedure
• Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
• Mixed aortic valve disease with predominant aortic regurgitation that is at least moderate
• Untreated clinically significant coronary artery disease requiring revascularization
• Left Ventricular Ejection Fraction (LVEF) < 50%
• Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL/min/1.73m2 by the MDRD equation or requiring dialysis)
• Blood dyscrasias as defined: leukopenia (WBC < 3000mm3), acute anaemia (Hb < 9g/dL), thrombocytopenia (platelet count < 50,000 cells/mm3); history of bleeding diathesis or coagulopathy
• Life expectancy <6 months
• Rockwood frailty score >6
• Moderate-severe mitral regurgitation and/or mitral stenosis
• Congenital unicuspid or congenital bicuspid aortic valve as verified by echocardiography or CT
• On or planned oral anticoagulation
• Those lacking capacity to consent or are deemed vulnerable adults
• Requires permanent pacemaker
• Pregnancy or the possibility of pregnancy as reported by the participant