Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 主要终点
- Primary end point: the incidence of all-cause death 12 months after operation
研究概览
简要总结
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
详细描述
This study is a prospective / retrospective, multicenterstudy after listing. The researchers preliminarily confirmed that they could be enrolled in this study according to the diagnosis of the subjects' medical history. After fully informed, they signed the informed consent, and met the TAVR inclusion requirements (see the inclusion criteria for details). At the same time, they registered the subjects in multiple centers. After the start of the trial, the participants were enrolled in the study, All the subjects who met the inclusion criteria but did not meet the discharge criteria were registered in the central registration system. The patients were followed up for 30 days, 6 months and 12 months, and followed up by telephone for 2, 3, 4 and 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic valve stenosis, defined as follows:
- •Symptomatic patients:
- •The mean differential pressure measured by echocardiography ≥ 40mm Hg
- •Or peak aortic ejection ≥ 4.0 m / S
- •Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2)
- •Asymptomatic patients:
- •Severe aortic stenosis and aortic valve area ≤ 1.0cm ²（ 6 cm2 / m2) with aortic ejection peak value ≥ 5.0 M / s or mean pressure difference measured by --echocardiography ≥ 60 mm Hg;
- •Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with limited exercise tolerance test, abnormal blood pressure response or arrhythmia;
- •Or aortic valve area ≤ 1.0cm ²（ Or AVA index ≤ 0.6 cm2 / m2), combined with aortic ejection peak ≥ 4.0 m / s or average differential pressure measured by echocardiography ≥ 40 mm Hg, combined with LVEF < 50%
- •Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
- •The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
- •Be able to contact the subjects or their legal guardians / relatives;
- •The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)
- •Note: for dead subjects, they must meet 1, 2 and 5 at the same time before they can be included in the group.
排除标准
- •Contraindications to any artificial biological valve implantation;
- •Any known allergies or contraindications;
- •Aspirin or heparin and bivalirudin;
- •Tigrelol and clopidogrel;
- •Nickel titanium alloy;
- •Contrast medium;
- •The patient is currently participating in drug or device research;
- •The patient is pregnant or lactating;
- •Aortic annulus diameter < 17 mm or > 32 mm;
- •The diameter of approach vessel was less than 5.0mm;
- •The investigator believes that the patient is not suitable to participate in this study or complete the follow-up specified in the protocol;
结局指标
主要结局
Primary end point: the incidence of all-cause death 12 months after operation
时间窗: 12 months after aortic valve replacement
After subjects completed aortic valve replacement surgery, whether prospectively or retrospectively, all-cause mortality at 12 months after operation was collected according to the time node of subjects' enrollment
次要结局
- The compound incidence of death, surgery, severe stroke, life-threatening bleeding, serious vascular complications and acute renal failure (within 30 days after operation);(Within 30 days after aortic valve replacement)
- The implantation rate of permanent pacemaker within 30 days;(Within 30 days after aortic valve replacement)
- All stroke (disabled or not disabled) within 12 months and 2, 3, 4 and 5 years(12 months and within 2, 3, 4 and 5 years)
- the incidence of life-threatening bleeding within 12 months and 2, 3, 4 and 5 years;(12 months and within 2, 3, 4 and 5 years)
- The incidence of reoperation due to dysfunction of prosthetic valve within 12 months and 2,3,4,5 years;(12 months and within 2, 3, 4 and 5 years)
- The incidence of readmission due to symptoms and signs of aortic valve disease within 12 months and 2,3,4,5 years;(12 months and within 2, 3, 4 and 5 years)
- The incidence of prosthetic valve dysfunction at 12 months (moderate or severe stenosis or reflux by ultrasonography);(12 months and within 2, 3, 4 and 5 years)
- The incidence of thrombus in clinical and subclinical prosthetic heart valves at 12 months;(12 months after aortic valve replacement)
研究者
Yaling Han, M.d., Ph.D.
Academlcan/chief physician
CCRF Inc., Beijing, China