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New treatment option for Aortic Stenosis, Severe
Official title A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
ClinicalTrials.gov ID: NCT06596460
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, England, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, England, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.