All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 130
- 主要终点
- Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
研究概览
简要总结
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis
详细描述
Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis.
Patients in both arm will receive anticoagulants according to routine practice of the hospital.
Patients will be followed-up until 1 year after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease)
- •Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II
- •ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm
- •Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm.
- •Subject with a documented local Heart Team (HT) indication for TF TAVI
- •Life expectancy longer than 1 year.
- •Willingness to undergo clinical and echocardiographic follow-up after the procedure.
- •Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements
排除标准
- •Non-calcific acquired aortic stenosis
- •Native unicuspid/bicuspid aortic valve or congenital aortic abnormality
- •Previous implantation of heart valve in any position
- •Severe aortic regurgitation (> 3+)
- •Severe mitral regurgitation (> 3+)
- •Severe tricuspid regurgitation (> 3+)
- •Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%)
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Untreated cardiac conduction disease in need of pacemaker implantation
- •Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent
- •Any need for emergency surgery
- •Any active bleeding that precludes anticoagulation
- •Liver failure (Child-C)
- •End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min
- •Pulmonary hypertension (systolic pressure > 80mmHg)
- •A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to bovine and/or collagen, glutaraldehyde or contrast media
- •Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures
- •Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed
- •Subject under judicial protection, tutorship or curatorship (for France only)
研究组 & 干预措施
ALLEGRA
ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care
干预措施: ALLEGRA TAVI System TF (Device)
Balloon-expandable TAVI
Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care
干预措施: Ballon-expandable valve system (Device)
结局指标
主要结局
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
时间窗: At 30 Days
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
次要结局
- Early safety assessed by composite criteria(At 30 days)
- Technical success assessed by composite criteria(Up to the end of the time when patient exit the procedure room)
- Device success assessed by composite criteria(At 30 days)
- Clinical efficacy assessed by composite criteria(At 1 year)