Ross for Valve Replacement in AduLts Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial
研究概览
简要总结
This study evaluates two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure versus conventional aortic valve replacement using a biologic or mechanical heart valve. The Ross procedure replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span.
详细描述
Heart valves help control blood flow through the heart and, if diseased, may need to be replaced. After having a heart valve replaced, patients have a higher risk of death than people who have not had a valve replaced. In young adult patients, replacing the aortic heart valve with a mechanical valve halves their life-span compared to other people their age. Mechanical valves tend to form blood clots so they need long-term blood thinners that increase risk of bleeding and lower quality of life. Animal tissue valves reduce clotting and bleeding risks but wear out sooner and shorten patient life-span. An operation, called the Ross procedure, replaces a patient's diseased aortic valve with his/her own pulmonary valve and uses a donor valve in the pulmonary position which receives less stress than the aortic valve. The Ross procedure aims to improve valve durability with less clotting, avoiding use of blood thinners. Patients and physicians need a large, high-quality study comparing the Ross procedure and standard valve replacement to know if either approach is better.
The investigators will perform a 3-year feasibility study in seven sites, in Canada and abroad, to test the study design and ability to do a larger, conclusive study comparing the impact of the Ross procedure to standard valve replacement on survival without valve-related life-threatening complications. Patients will be randomized, like flipping a coin, to receive the Ross or standard valve surgery. The goals are 1) to evaluate if the investigators can recruit 6 patients per site per year, 2) to test if the assigned procedure is performed in over 90% of study patients, and 3) to see how many mechanical vs. tissue valves are used in the standard valve group. Patients eligible but not enrolled in the trial will be asked if the investigators can collect some data on how they do after their surgery. If the investigators show the study is feasible, they will proceed to the full study and will include the feasibility patients in the full study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60 years
- •Undergoing clinically indicated aortic valve replacement
- •Provided written informed consent
排除标准
- •Previous valve replacement not in the aortic position
- •Patients undergoing concomitant CABG or other valve procedure during aortic valve replacement
- •Known connective tissue disease
- •Severe (grade 3 or 4) right or left ventricular dysfunction
- •Pulmonary valve dysfunction or anomaly not compatible with the Ross procedure (as determined by the consulting cardiac surgeon)
- •Life expectancy less than 5 years (as determined by the consulting cardiac surgeon)
- •Documented severe aortic insufficiency not solely due to leaflet issue
- •Previous intervention on the pulmonary valve
结局指标
主要结局
Measure the pilot trial capacity to enrol a mean of 6 patients per centre per year to determine the feasibility of a full trial
时间窗: Through completion of the pilot trial, estimated to be 3 years
The outcome measures of the pilot trial, in order of importance, are: To evaluate the capacity to enroll a mean of 6 patients per centre per year.
The rate of compliance with allocation in the pilot trial to determine the feasibility of a full trial
时间窗: Through completion of the pilot trial, estimated to be 3 years
To determine the rate of compliance with randomization allocation.
Full trial primary outcome - The rate of survival free of a composite of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention)
时间窗: Through trial completion, estimated to be 10 years
The primary outcome is the rate of survival free of life-threatening valve-related complications (major bleeding, stroke or systemic thromboembolism, valve thrombosis, and operated-on valve reintervention) over duration of follow-up. Assessment of this composite over time is particularly important, as the Ross procedure may show initial benefit secondary to thromboembolic and bleeding reduction, however should the technique show high late rates of reoperation as suggested in some observational literature, the effect magnitude may change significantly over time.
Measure the proportions of type of conventional valve used in the pilot trial
时间窗: Through completion of the pilot trial, estimated to be 3 years
To validate the proportion of mechanical (at least 65%) versus biological (at most 35%) valves in the conventional arm.
次要结局
- The rate of perioperative and non-perioperative major bleeding over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- The rate of valve thrombosis per VARC criteria over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- Mean pulmonic valve gradient(Through trial completion, estimated to be 10 years)
- The rate of stroke or systemic thromboembolism over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- The rate of operated-valve endocarditis over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- The rate of pulmonary valve re-intervention over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- The rate of operated-on valve reintervention over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- Rate of mortality within 30 days post-operatively(30 days)
- Measure health related quality of life using the 36-Item Short Form Survey (SF-36) questionnaire over the duration of patient follow-up(Annually through trial completion, estimated to be 10 years)
- The rate of aortic valve re-intervention over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- Mean aortic valve gradient(Through trial completion, estimated to be 10 years)
- Severity of aortic valve regurgitation(Through trial completion, estimated to be 10 years)
- Severity of pulmonic valve regurgitation(Through trial completion, estimated to be 10 years)
研究者
Richard Whitlock
Associate Professor
McMaster University