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

Launched by BARTS & THE LONDON NHS TRUST · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to gather information about how well a new heart valve, called a Transcatheter Aortic Valve (TAVI), works after it is implanted in patients with severe aortic stenosis, a condition where the heart's aortic valve doesn't open properly. Researchers want to see if imaging tests, like a CT scan and a heart echo scan, taken before and after the TAVI procedure can help predict how well the new valve will perform in the future. Currently, patients usually only get a CT scan before the procedure, but this study will also include a follow-up scan six months after the TAVI to track any changes.

To participate, patients should be at least 18 years old, have severe aortic stenosis, and have undergone a successful TAVI procedure recently. Participants will need to agree to have a CT scan done six months after their valve replacement during a routine follow-up visit. If you are a patient or family member considering this study, it is an opportunity to contribute to important research that may improve future treatments for heart valve conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 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
• Exclusion Criteria:
• • Life expectancy \<6 months
• • Rockwood frailty score \>6
• • Mixed aortic valve disease with predominant aortic regurgitation that is at least moderate.
• • Moderate-severe mitral regurgitation and/or mitral stenosis.
• • Congenital unicuspid or congenital bicuspid aortic valve as verified by echocardiography or CT
• • Previous TAVI or Aortic Valve Replacement (AVR)
• • Left Ventricular Ejection Fraction (LVEF) \< 50%
• • On or planned oral anticoagulation
• • Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL/min/1.73m2 by the MDRD equation or requiring dialysis)
• • Evidence of an acute myocardial infarction within 30 days prior to index procedure
• • Untreated clinically significant coronary artery disease requiring revascularization
• • 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
• • Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude 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.