Imaging data collection for patients undergoing Transcatheter Aortic Valve Implantation

Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)

This study is collecting imaging data from patients with severe aortic stenosis who are getting a new heart valve to see if these scans can help predict how well the valve will work in the future.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Barts & The London NHS Trust (other)
• Locations: 1 site (London, England)
• Trial ID: NCT06596460 on ClinicalTrials.gov

What this trial studies

This study aims to gather imaging data from patients with severe aortic stenosis who are scheduled for Transcatheter Aortic Valve Implantation (TAVI). Participants will undergo Computed Tomography (CT) scans and TransThoracic Echo (TTE) scans before and after the TAVI procedure to evaluate the performance of the implanted valve. The collected data will be analyzed to determine if these imaging techniques can predict the future performance of the TAVI valve. The ultimate goal is to enhance the understanding of valve performance and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic, severe aortic stenosis.

Not a fit: Patients with mild or moderate aortic stenosis or those who do not require TAVI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better predictions of TAVI valve performance, potentially improving patient outcomes and management.

How similar studies have performed: While the approach of using imaging data to predict valve performance is promising, it is relatively novel and has not been extensively tested in similar studies.

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.

Where this trial is running

London, England

• St Bartholomew's Hospital — London, England, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Anthony Mathur, Prof — Queen Mary University of London
• Study coordinator: R&D Governance Administrator

Conditions: Aortic Stenosis, Severe, Aortic Valve Stenosis, Heart, Valve, Implantation, Transcatheter, CT, Computerised Tomography