Trifecta Comparative Stress Hemodynamic Study (Randomized Comparison of Exercise Hemodynamics and Left Ventricular Remodeling With Aortic Bioprostheses After Aortic Valve Replacement for Aortic Stenosis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
研究概览
简要总结
The purpose of this study is to:
- Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves.
- Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.
详细描述
Various aortic valve prostheses have unique hemodynamic characteristics, and there is on-going interest in defining those hemodynamic characteristics in the interest of avoiding residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow obstruction despite a normally functioning prosthesis ) after aortic valve replacement. Attempts to compare hemodynamics between prostheses have been limited by different sizing systems used by various manufacturers (precluding meaningful comparison of valves by valve size) and biological variability of in vivo gradients and effective orifice area for any valve (making potentially small differences in hemodynamics difficult to detect). Assessment of hemodynamics during increased cardiac output associated with exercise testing has been used to better define potentially subtle differences in hemodynamics between valve prostheses. In addition, assessment for change in LV geometry (notably including LV hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic prosthesis hemodynamics.
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
- None
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
- •Age ≥ 18 years.
- •Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m
- •Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS.
- •Less than moderate aortic regurgitation on preoperative testing.
- •Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation.
- •Left ventricular ejection fraction ≥ 40% on preoperative testing.
- •Physically able and willing to pedal a recumbent bicycle.
- •Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis.
- •Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria.
- •Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement.
- •Willing and able to undergo preoperative echocardiography/Doppler for purposes of the research study.
- •Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
排除标准
- •Age < 18 years.
- •AS felt by overall clinical impression to be less than severe.
- •Aortic valve replacement is urgent or emergent.
- •Moderate of more aortic regurgitation on preoperative testing.
- •Concomitant mitral or tricuspid valve replacement.
- •Left ventricular ejection fraction < 40% on preoperative testing.
- •Physically unable or unwilling to pedal a recumbent bicycle.
- •Planned aortic valve replacement with a mechanical prosthesis.
- •Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria.
- •Not willing to undergo randomization to have implanted one of three bioprosthesis.
- •Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of the research protocol.
- •Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.
研究组 & 干预措施
Freestyle
Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).
干预措施: Aortic valve replacement (Device)
Magna Ease
Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).
干预措施: Aortic valve replacement (Device)
Trifecta
Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).
干预措施: Aortic valve replacement (Device)
结局指标
主要结局
Aortic Valve Mean Gradient (mm Hg) at Peak Exercise
时间窗: 6 months after aortic valve replacement
This is a measure of the resistance to flow across the aortic bioprosthesis.
次要结局
未报告次要终点
研究者
David Bach, MD
Professor of Medicine
University of Michigan