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

NCT06596460 | Recruiting

• 1 other identifier: 164073
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 (TAVI) procedure can be used to predict how the new TAVI valve will perform in the future. To do this the investigators need the usual CT scan before and a new CT scan after the TAVI valve has been put in. At present a CT scan after TAVI procedure is not routinely done. Male and female patients with severe Aortic Stenosis (AS) will be asked to take part. The data from the scans along with routine measures that are taken will be used to assess if there has been any deterioration in the valve at six months. The scan data collected will be used in a computer programme. This programme will be trained to predict TAVI valve performance. The main purpose of this study is to collect the CT scan data before and after the TAVI procedure. The study aims to answer: • Can the investigators obtain additional CT imaging data and other data before and after TAVI to enable the prediction of valve performance? Participants will be asked if they would have another CT scan 6 months after their TAVI procedure, during their routine follow up.

Conditions

Aortic Stenosis, Severe; Aortic Valve Stenosis

Keywords

Heart; Valve; Implantation; Transcatheter; CT; Computerised Tomography

Outcome Measures

Primary Outcomes (1)

• The number of participants with quality TAVI CT imaging data post TAVI procedure.

  Quality (high-good resolution and without artifacts) retrospectively ECG-gated scan of the heart, aortic annulus and ascending aorta to the first branch vessel. The full body angiogram, best systole and best diastole must be present.

  At 6 months

Secondary Outcomes (5)

• The occurrence of Patient/Prosthesis mismatch (PPM) - as measured by a transvalvular gradient >10 mmHg

  At Day 1 post TAVI

• The occurrence of haemodynamic valve deterioration as measured by Transthoracic echocardiography (TTE)

  At Day 1 post TAVI and 6 months

• The occurrence of hypo attenuated leaflet thickening (HALT) as reported by radiologist utilising CT scan

  At 6 months

• Change in New York Heart Association (NYHA) class score I to IV

  At baseline and at 6 months

• The occurrence of major adverse cardiac events (MACE) (defined as: cardiovascular death, stroke, myocardial infarction and cardiac reintervention [including stent insertion])

  At 6 months

Study Arms (1)

Computerised Tomography (CT) Intervention

EXPERIMENTAL

Transpercutaneous Aortic Valve Implantation (TAVI) planning CT (adapted) of the heart and aortic arch at 6 months post TAVI

Diagnostic Test: TAVI planning CT (adapted)

Interventions

TAVI planning CT (adapted) DIAGNOSTIC_TEST

TAVI planning CT (adapted) to obtain a standard assessment of the Left Ventricular Outflow Tract (LVOT), valve annulus, aortic root, and ascending aorta up to neck branches. There will be no requirement to scan the ilio-femoral arteries as per standard TAVI planning CT

Computerised Tomography (CT) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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;
• D LVOT diameter in plax view.
• In sinus rhythm at time of any TTE or CT scans

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• Anthony Mathur, Prof

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R&D Governance Administrator

CONTACT

+44 (0)20 7882 6826; research.governance@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single centre, prospective, interventional study in 40 patients undergoing TAVI in a National Health Service (NHS) hospital

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: September 19, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): September 12, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

GB (1)