Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Left Ventricular Reverse Remodelling
研究概览
简要总结
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
详细描述
The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.
Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic NoIschemic cardiomyopathy
- •EROA> 0,2 cm2 or Regurgitant Volume > 30 ml (ESC guidelines).
- •EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
- •MR Grade 3/4
- •Eligible for TEE, surgical repair and replacement of mitral valve
- •Coronary artery disease with or without the need for coronary revascularization
- •Average value LVEDD 62 mm LVEF 42%
排除标准
- •Pediatric
- •Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
- •ruptured papillary
研究组 & 干预措施
Transcatheter Edge to Edge Repair
TEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure.
干预措施: Trancatheter Edge to Edge Repair (Device)
Mitral Valve Replacement
Mitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required
干预措施: Mitral Valve Replacement (Procedure)
Restrictive Mitral Annuloplasty
RMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle.
干预措施: Restrictive Mitral Annuloplastie (Procedure)
Restrictive Mitral Annuloplastie Plus Subvalvular Repair
RMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required
干预措施: Restrictive Mitral Annuloplastie/Subvalvular Repair (Procedure)
结局指标
主要结局
Left Ventricular Reverse Remodelling
时间窗: 5 years
The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography
次要结局
- Echocardiographic Parameter Changes (LVEF)(5 years)
- Echocardiographic Parameter Changes (recurrence)(5 years)
- Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)(5 years)
- Echocardiographic Parameter Changes ( interpapillary distance)(5 years)
- Overall Mortality(5 years)
- Cardiac Death(5 years)
- Major Adverse Cardiac or Cerebrovascular Events (MACCE)(5 years)
- Echocardiographic Parameter Changes (LVEDD)(5 years)
- Echocardiographic Parameter Changes (Mitral Valve tenting area and height)(5 years)
- Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)(5 years)
研究者
Francesco Nappi
Principal Investigator
Centre Cardiologique du Nord