Early Versus Deferred Aortic Valve Replacement in Patients With Moderate Aortic Stenosis Combined With Mitral Regurgitation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The primary outcome will be a composite of all-cause death, stroke, and unplanned hospitalization for heart failure related to valvular heart disease at 2 years.
研究概览
简要总结
The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.
详细描述
In more than one-half of all patients with valvular heart disease, more than a single valve is involved. Valvular aortic stenosis coexists with significant mitral valve disease in up to one-third of patients undergoing aortic valve replacement (AVR).
Guidelines for the management of valvular heart disease provide recommendations for isolated valvular lesions; data to guide timing of intervention in patients with multivalvular disease is however scarce. Currently, patients with moderate aortic stenosis (AS) in combination with mitral regurgitation have an indication for aortic valve replacement (AVR) only if the concomitant mitral regurgitation meets an indication for surgery. However, the hemodynamic stress of combined valvular lesions is greater than its individual components, and patients may benefit from early intervention.
Furthermore, the presence of multivalvular heart disease complicates the assessment of individual valvular lesions. In patients with combined AS and mitral regurgitation (MR), increased left ventricular pressure exacerbates the mitral regurgitant volume. Conversely, decreased forward flow across the aortic valve underestimates the severity of aortic stenosis when assessed by a pressure gradient.
Standard cut-off values inadequately reflect the hemodynamic stress in concomitant aortic and mitral valve disease, and recommendations for the timing of valvular replacement fail to account for the complex interplay of multiple valvular lesions.
Timing of intervention in patients with combined AS and MR is therefore challenging and evidence on the optimal timing of intervention is scarce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Moderate native aortic stenosis defined by an aortic valve area (AVA) ≤1.5 cm2 and >1.0 cm2 and transvalvular mean gradient ≥20 mmHg and <40 mmHg.
- •Primary or secondary mitral regurgitation (at least moderate) defined by effective regurgitant orifice area (EROA) ≥20 mm2 or regurgitant volume ≥30 ml
- •New York Heart Association (NYHA) functional class ≥2
排除标准
- •Life expectancy <1 year irrespective of valvular heart disease
- •Left ventricular ejection fraction <30% or LVESD >70mm
- •Echocardiographic evidence of severe right ventricular dysfunction
- •Untreated clinically significant CAD requiring revascularisation
- •Moderate or severe aortic regurgitation
- •Severe tricuspid valve disease requiring intervention
- •Symptomatic patients with severe primary MR who are operable and not high risk
- •Patients with severe secondary MR who remain symptomatic despite optimal medical therapy and who are judged appropriate for transcatheter edge-to-edge repair or surgery by the Heart Team
- •Transcatheter or surgical treatment of valvular and/or coronary artery disease within 90 days prior to randomization
- •COPD with home oxygen therapy
- •Estimated or measured systolic PAP >70 mmHg
- •Stroke within 30 days prior to the randomization
- •Inability to provide written informed consent
- •Participation in another cardiovascular trial before reaching the primary endpoint.
结局指标
主要结局
The primary outcome will be a composite of all-cause death, stroke, and unplanned hospitalization for heart failure related to valvular heart disease at 2 years.
时间窗: 2 years
次要结局
- Aortic or mitral valve re-intervention(5 years)
- Neurologic events(5 years)
- Hospitalization for heart failure(5 years)
- Cardiovascular death(5 years)
- NYHA functional class(5 years)
- The evaluation Health-related quality of life assessment by means of the KCCQ 12 questionnaire(5 years)
- All-cause death(5 years)
- New-onset atrial fibrillation(5 years)
- Implantation of a permanent pacemaker(5 years)
- Days alive out of hospital (DAOH)(5 years)