NCT05977257尚未招募不适用
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
Shanghai MicroPort CardioFlow Medtech Co., Ltd.4 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- All cause mortality
研究概览
简要总结
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
详细描述
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.
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
- •Must meet 1, 2, 3, 4 or 1, 5 to be selected:
- •Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;
- •Be able to get in touch with the patient or his legal guardian/relative;
- •Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;
- •Sign the informed consent form;
- •Patients who are known to have died.
- •4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.
排除标准
- •Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
- •The investigator judges that the patient's compliance is poor and the study cannot be completed as required.
结局指标
主要结局
All cause mortality
时间窗: 7years after the operation
rate of all cause mortality
次要结局
- Stroke(6 years, 7 years, 8 years, 9 years and 10 years after the operation)
- class of Aortic regurgitation(7years,and 10 years after the operation)
- bioprosthetic valve failure，BVF(7years,and 10 years after the operation)
- Cardiac death(6 years, 7 years, 8 years, 9 years and 10 years after the operation)
- Serious Adverse Event(6 years, 7 years, 8 years, 9 years and 10 years after the operation)
- Blood pressure(6 years, 7 years, 8 years, 9 years and 10 years after the operation)
- Effective orifice area(7years,and 10 years after the operation)
- Peak velocity(7years,and 10 years after the operation)
- class of Paravalvular leak(7years,and 10 years after the operation)
- valve-related rehospitalization(6 years, 7 years, 8 years, 9 years and 10 years after the operation)
- The 12-Item Short Form Health Survey (SF-12)(6years, 7years, 8 years, 9 years and 10 years after the operation)
- Mean transvalvular pressure gradient(7years,and 10 years after the operation)
- New York Heart Association Class for heart function(7years,and 10 years after the operation)
- Natriuretic peptide tests ( NT Pro-BNP or BNP)(7years,and 10 years after the operation)
- Kansas City Cardiomyopathy Questionnaire(7years,and 10 years after the operation)
- moderate and severe structural valve deterioration SVD(7years,and 10 years after the operation)
- All cause mortality(6 years, 8 years, 9 years and 10 years after the operation)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
不适用
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuREAortic StenosisNCT06777368Medtronic Cardiovascular225
进行中（未招募）
不适用
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).Severe Aortic StenosisNCT01586910Medtronic Cardiovascular1,746
尚未招募
不适用
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast ChinaSevere Aortic Valve StenosisNCT04988243CCRF Inc., Beijing, China320
招募中
不适用
Hydra Registry - UKAortic Valve StenosisNCT06507579Sahajanand Medical Technologies Limited250
已完成
不适用
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction SystemTranscatheter Aortic Valve ReplacementHeart BlockAortic StenosisNCT04982406Beth Israel Deaconess Medical Center409