On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 510
- 试验地点
- 33
- 主要终点
- Major bleeds
研究概览
简要总结
The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).
详细描述
The study is a prospective, multicenter, observational single arm study of newly-enrolled patients treated with the On-X Aortic Prosthetic Heart Valve. Assuming 20% attrition over 5 years and 40% of enrolled patients will be high risk home monitoring patients, 510 patients will be enrolled in the study. Patients will be under standard anticoagulation (INR 2.5 (2.0-3.0 range)) for at least 3 months before initiation of low dose (INR 1.8 (1.5-2.0 range)) anticoagulation treatment.
All centers will follow a common protocol in which eligible patients will be entered into the registry within 1 year after receiving the On-X Aortic Prosthetic Heart Valve. No special diagnostic or therapeutic procedures will be done for the purposes of the protocol and data will be collected prospectively on each patient for 5 years.
Data from all consenting patients at participating sites receiving the On-X Aortic Prosthetic Heart Valve will be entered into an online registry database. Patients will be recruited postoperatively within 1 year, most typically at the first post-discharge visit at between 2 and 6 weeks but also by special visit to their surgeon if agreed. Low dose therapy will begin no earlier than 3 months postop. Data entry is non-randomized, and continues until the sample size requirements are met and the enrollment into the registry is closed. To minimize bias all patients meeting the inclusion/exclusion criteria will be recruited and those agreeing to participate in the follow-up will be entered into the database. A screen failure log of those patients not agreeing to participate will be kept and entered identifying reasons for declined enrollment. Once entered patients will be analyzed as a whole and separated into groups by TE risk factors and warfarin monitoring method. All patients that have no contraindication for aspirin will be prescribed a daily 'baby' aspirin (75-100mg) for consistency to prior research and to current society guidelines.
The primary hypothesis for the registry is to confirm the results seen in the IDE trial, showing that using home monitoring or anticoagulation clinic with an INR target of 1.8 (range 1.5 to 2.0) does not significantly increase patient risk relative to current standard of practice.
The primary analysis will compare the overall composite event rate for the following events:
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
- •Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve (ONXA, ONXAE, ONXAC, ONXACE, ONXAN, ONXANE) implant, without or without concomitant procedures, and agreed to participate in the registry.
- •Life expectancy of at least 5 years.
- •Patients whose operation occurred within the year prior to recruitment.
排除标准
- •Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On-X mitral valve; i.e. no mitral or multiple valve implants.
- •Patients with a prior history of arterial thromboembolic events, or who have such events or On-X valve thrombosis after AVR and prior to recruitment.
- •Death prior to discharge or recruitment.
- •Patients whose surgery predates enrollment by more than 1 year.
研究组 & 干预措施
On-X Aortic Heart Valve replacement
Patients with On-X Aortic Valve maintained on low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring.
干预措施: On-X Aortic Heart Valve replacement (Device)
结局指标
主要结局
Major bleeds
时间窗: 5 years
Event rates for major bleeds
Thrombotic events
时间窗: 5 years
Rates of occurrence for thromboembolism and/or thrombosis
次要结局
- Death(5 years)