A Prospective, Multicenter, Post-market Clinical Investigation to Evaluate the Pre-dilation Safety and Effectiveness of Alwide Plus Balloon Catheter of MicroPort CardioFlow in Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Percentage of patients with TAVI device success at immediate post-procedure
研究概览
简要总结
This is a prospective, single-arm, multi-center, post-market registry study conducted in China. The purpose is to evaluate the safety and effectiveness of the AlwideTM Plus balloon catheter for pre-dilatation of the aortic valve during TAVR in the real-world setting.
详细描述
The study is designed to evaluate the safety and effectiveness of the Alwide Plus balloon catheter for pre-dilatation of the aortic valve during in transcatheter aortic valve replacement in the real-world setting, with TAVI device success at immediate post-procedure as the primary endpoint. The immediate post-procedural pre-dilation success, all-cause mortality, stroke, bleeding, acute kidney injury, permanent pacemaker implantation, major vascular complication, valve function at post-procedure and discharge, and post-dilation success will be used as secondary endpoints.This is a prospective, multi-center, post market clinical investigation. 75 patients will be enrolled in this clinical investigation. All subjects will undergo telephone follow-up at 30 days post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age≥18 years old;
- •Severe aortic stenosis verified by echocardiogram: mean transvalvular gradient≥40mmHg (1mmHg=0.133kPa), or peak aortic jet velocity≥4m/s, or aortic valve area (AVA) ≤ 1.0cm2 (or AVA index≤ 0.6cm2/m2);
- •Patients, who can understand the clinical investigation purpose, voluntary agree and sign the informed consent form, and willing to comply with relevant trial assessments and clinical follow up
排除标准
- •Aortic valve anatomy or lesion unsuitable or not necessary for balloon pre-dilation during the TAVR procedure
- •TAVR procedure in trans-apical access
- •Pre-implanted mechanical or bioprosthetic valve at the aortic valve position
- •Acute myocardial infarction (MI) occurred in the last 30 days before the treatment；
- •LVOT obstruction;
- •Serious left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%
- •Echocardiographic evidence of intracardiac mass, thrombus or neoplasm；
- •Unable to receive anticoagulation or antiplatelet therapy；
- •Allergy to nitinol or sensitive contrast media；
- •Active bacterial endocarditis or other active infection may affect the procedure；
- •Aortic valve anatomy , lesion, or other situation unsuitable for the prosthesis valve implantation as assessed by the investigator team；
- •Life expectancy > 12 months；
- •vulnerable individuals who are unable to give informed consent/ unable to fully understand all aspects of the investigation or Severe incapacitating Alzheimer's disease；
- •Patients who participated in other clinic trials of drugs or medical device before being enrolled for which the primary endpoint follow up duration has not been reached；
- •Investigators determined that patients have poor compliance and can't complete the study as required
结局指标
主要结局
Percentage of patients with TAVI device success at immediate post-procedure
时间窗: Immediate post-procedure
TAVI device success, defined as (meeting all the following criteria): Freedom from mortality; Successful access, delivery, deployment, implantation of the valve, and retrieval of the delivery system; Correct positioning of the prosthetic heart valve into the proper anatomical location; Intended performance of the valves (mean gradient \<20mmHg, or peak velocity \<3 m/s, and no severe aortic regurgitation or paravalvular leakage).
次要结局
- Percentage of patients with balloon pre-dilation success(Immediate post-procedure)
- Percentage of paitents with balloon post-dilation success(Immediate post-procedure)
- Incidence of all-cause mortality, disabling and non-disabling stroke, life-threatening or disabling bleeding, major bleeding, acute kidney injury(AKIN≥2), major vascular complications and new permanent pacemaker implantation(Immediate post-procedure and 30 days post-procedure)
- Prosthetic valve performance-orifice area(Immediate post-procedure and discharge(within 7 days post-procedure))
- Prosthetic valve performance-mean transvalular pressure gradient(Immediate post-procedure and discharge(within 7 days post-procedure))
- Prosthetic valve performance-valve regurgitation(intra- and para valvular leakage)(Immediate post-procedure and discharge(within 7 days post-procedure))