Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- number of all cause death patients in 30 days following TAVI/total TAVI patients
研究概览
简要总结
Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Nr. of all cause death patients at 30 days following TAVI/total patients
入排标准
- 年龄范围
- 75 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient > 40 mmHg or jet velocity > 4.0 m/s aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
- •Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class > = II
- •Age >= 75 years old
- •Patients with prohibitive risk established in the Heart Team and defined on the basis of the following clinica instrument criteria according with the Varc-2 consensus.
- •High surgical risk (%, logES>20%, EuroSCORE II > 9 and STS score > 8%)
- •Porcelain aorta (heavy circumferential calcification or severe atheromatous plaques that do not allow clamping.
- •Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, complications form to previous surgery, evidence of severe radiotion damege, history of multiple recurrent pleural effusions causing internal adhesions.
- •Fragilty (slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence, BMI < 20 Kg/m2 and or weight loss 5 kg/year, serum albumin < 3,5 g/dl, cognitive impairment or dementia)
- •Severe liver disease/cirrosis
- •Presence of a patent graft of an internal mammary artery crossing mildline and/or adherent to posterior table of sternum
- •Severe pulmoary hypertension
- •Severe right ventricular dysfunction
- •Transfemoral access allowed
- •Signature of informed consent
排除标准
- •Tavi in case of aortic valve bioprosthesis (TAVI valve-in valve)
- •controindication to femoral access
- •Bicuspid aortic valve
- •Instrumental characteristics, evaluated by angioTC, associated with an increased risk of major complications: severe left ventricle outflow tract or sub annular calcification, condition associated with an increased risk of rupture of the valve ring, presence of complex aortic plaques correlated with the possibility of dissection, valvular ring-coronary ostia distance < 10 mm associated with a high probability of coronary obstruction, severe aortic root dilatation or out of range aortic annulus diameters for TAVI are not complatible for safe valve implatation.
结局指标
主要结局
number of all cause death patients in 30 days following TAVI/total TAVI patients
时间窗: 4 weeks
the simple size calculation is based on the primary endpoint mortality at 30 days. Considering a standard incidence of 6-7% 200 patients will be needed to demonstrate, wuth an alpha error of 5% the non inferiority of the alternative treatment compared to the standard considering a non inferiory margin of 3% such as to exclude mortaluty values higher than 10%, in relation at the upper limit of the 90% confidence interval calculated with the exact method of clopper and Pearson.
次要结局
未报告次要终点