Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT06596460
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06596460
Study Brief:
Protocol Section:
NCT06596460