Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 16
- 主要终点
- Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
研究概览
简要总结
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
详细描述
In the VIVALL.2 study, 104 patients with severely degenerated biological aortic surgical valve accepted for vave-in-valve procedure (transcatheter aortic valve implantation) will be randomized to be treated with the self-expandable supra-annular Allegra or the balloon-expandable intra-annular Edwards systems. The primary end-point will be trans-aortic mean gradient determined by trans-thoracic echocardiography at 30 days. The proportion of patients with moderate or severe prosthesis mismatch at 30 days will be a secondary end-.point. Different countries will participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting ALL the following criteria will be included:
- •Patients aged ≥ 18 years.
- •Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area < 1.0 cm2) and/or severe valve regurgitation.
- •The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease.
- •Heart team decision of VIV procedure.
- •Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.
排除标准
- •Patients meeting, at least, 1 of the following criteria will be excluded:
- •Patients who openly express their refusal to participate in the study.
- •Female patients in gestational age.
- •Presence or suspicious of biological aortic valve thrombosis.
- •Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
- •Ongoing sepsis and/or suspicious or diagnosis of endocarditis.
- •Patients whose life expectancy is < 1 year due to non-cardiac comorbid conditions.
- •Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams.
- •True inner diameter of the prosthetic valve > 27 mm.
- •Transfemoral access inadequate to accommodate an 18F sheath.
- •Patients included in other clinical trials (excluding registries).
研究组 & 干预措施
NVT ALLEGRA System TF
NVT ALLEGRA System TF
干预措施: NVT ALLEGRA TAVI System TF (Device)
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
干预措施: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM (Device)
结局指标
主要结局
Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
时间窗: 30 days
Trans-aortic mean gradient after Valve-in-Valve procedure, measured by transthoracic echocardiography (TTE).
次要结局
- Proportion of patients with a trans-aortic mean gradient higher than 20 mmHg after the VIV procedure(30 days)
- Early safety at 30 days as defined by Valve Academic Research Consortium 3 (VARC-3) criteria(30 days)
- Clinical efficacy at 1 year as defined by VARC-3 criteria(1 year)
- Death(1 year)
- Trans-aortic mean gradient(1 year)
- Stroke(1 year)
- Proportion of patients with device success after the Valve In Valve (VIV) procedure(30 days)
- Proportion of patients with moderate or severe prosthesis mismatch 30 days after the VIV intervention.(30 days)