Imaging data collection for patients undergoing Transcatheter Aortic Valve Implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: research.governance@qmul.ac.uk
• Phone: +44 (0)20 7882 6826

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.