Status:
RECRUITING
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Queen Mary University of London
Conditions:
Aortic Stenosis, Severe
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation ...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 12 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06596460
Start Date
July 9 2024
End Date
September 12 2026
Last Update
September 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE