Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Aortic Stenosis, Severe
- 发起方
- Barts & The London NHS Trust
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The number of participants with quality TAVI CT imaging data post TAVI procedure.
- 状态
- 招募中
- 最后更新
- 8个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •≥ 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
排除标准
- •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
结局指标
主要结局
The number of participants with quality TAVI CT imaging data post TAVI procedure.
时间窗: At 6 months
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.
次要结局
- 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)