Ross for Valve Replacement in AduLts (REVIVAL) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Evaluation of systematic differences between registry and trial patients
研究概览
简要总结
This registry follows patients undergoing two methods of aortic heart valve replacement in adults aged 18-60, the Ross procedure or 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. The REVIVAL Registry will run in parallel with the REVIVAL randomized trial.
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. In parallel to the REVIVAL Registry, a REVIVAL Randomized Trial will also take place.
Patients included in randomized trials often systematically differ from those who are not. By creating a registry of patients who are eligible for but not recruited into the REVIVAL trial, the investigators will better understand: 1) the reasons for not including these patients; 2) how those patients differ in terms of baseline characteristics from the trial cohort; 3) whether the outcomes of registry participants differ from those in the trial, assessed by treatment group. The registry will aid in understanding the generalizability of the results that the trial produces.
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 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
Evaluation of systematic differences between registry and trial patients
时间窗: Through REVIVAL Trial completion, estimated to be 10 years
The primary outcome of the REVIVAL registry is to examine for systematic differences between the demographics and outcomes of patients enrolled in the REVIVAL trial and patients not enrolled in the trial. We will use descriptive statistics including mean (standard deviation), median (interquartile range), and count (proportion) to describe the REVIVAL registry cohort.
次要结局
- The rate of operated-valve endocarditis over the duration of patient follow-up(Through trial completion, estimated to be 10 years)
- Evaluate the number of patients meeting eligibility criteria for the REVIVAL trial per month who are not enrolled into the trial.(Through completion of the pilot trial, estimated to be 3 years)
- The rate of aortic valve re-intervention 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)
- Mean aortic valve gradient.(Through trial completion, estimated to be 10 years)
- 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 stroke or systemic thromboembolism over the duration of patient follow-up.(Through trial completion, estimated to be 10 years)
- Evaluate the proportion of Ross procedures compared to conventional aortic valve replacement.(Through completion of the pilot trial, estimated to be 3 years)
- 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)(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)
- 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(Through trial completion, estimated to be 10 years)
- Severity of aortic valve regurgitation.(Through trial completion, estimated to be 10 years)
- Mean pulmonic valve gradient(Through trial completion, estimated to be 10 years)
- Severity of pulmonic valve regurgitation(Through trial completion, estimated to be 10 years)