The Safety and Feasibility of the SAPIEN XTTM Transcatheter Heart Valve With NovaFlex and Ascendra Delivery Systems and SAPIEN 3 With Commander Delivery System in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification and Patients With Failing Mitral Surgical Rings or Bioprostheses Who Are Not Candidates for Mitral Valve Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 15
- 主要终点
- Mitral Valve Gradient (MVG)
研究概览
简要总结
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.
详细描述
Design:
A prospective pilot study enrolling extremely high surgical risk patients with symptomatic severe calcific mitral valve disease undergoing implantation of an Edwards Sapien XT or SAPIEN 3 valve in the mitral position.
There are three arms in this study evaluating three separate patient populations described below:
- Native Mitral Valve with severe Mitral Annular Calcification (MAC): Patients with symptomatic severe disease of a native mitral valve due to severe mitral annular calcification.
- Valve-in-Ring: Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis.
- Valve-in-Valve: Patients with failing bioprosthetic surgical valves with severe regurgitation or stenosis
The delivery approaches include: standard transeptal, modified transeptal approach with a guidewire externalized through a sheath percutaneously placed in the left ventricle, surgical trasnapical and surgical transatrial delivery approach with or without surgical resection of the anterior mitral valve (MV) leaflet (in the native mitral valve arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •in Native Mitral Valve arm
- •All Candidates must meet the following criteria:
- •Patient has severe calcific native mitral valve stenosis with mitral annular calcification with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2, or severe mitral regurgitation with severe mitral annular calcification and at least moderate mitral valve stenosis. Qualifying echo must be within 60 days of the date of the procedure.
- •Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.
- •The patient is at least 22 years old.
- •The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
- •The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the STS score is ≥15% or the probability of death or serious, irreversible morbidity is ≥ 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in the patient (some medical factors and definitions are provided below). At least one of the cardiac surgeon assessors must have physically evaluated the patient. All patients must be approved by the Patient Selection and Procedure Management Steering Committee (at least 2 member votes, one must be a cardiac surgeon).
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
- •Inclusion Criteria in Valve-in-Ring arm
- •All Candidates must meet the following criteria:
- •Patient has a failing surgical ring in the mitral position with severe mitral regurgitation or stenosis (echocardiographically derived mitral valve area [MVA] of ≤1.5 cm
- •Qualifying echo must be within 60 days of the date of the procedure.
- •Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test, or severe hemolytic anemia requiring blood transfusions and no other cause of hemolytic anemia is found after extensive work up.
- •Inclusion Criteria items #3 to 7 will be the same as in Native MV arm described above
- •Inclusion Criteria in Valve-in-Valve arm
- •All Candidates must meet the following criteria:
- •Patient has a failing surgical bioprosthesis in the mitral position with severe mitral regurgitation or stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm
- •Qualifying echo must be within 60 days of the date of the procedure.
- •Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test.
- •Inclusion Criteria items #3 to 7 will be the same as in Native MV arm described above
排除标准
- •Candidates will be excluded from the study if any of the following conditions are present:
- •Heart Team assessment of operability (the heart team considers the patient is a surgical candidate).
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- •Mitral annulus is not calcified (only applies to patients included in Native MV arm).
- •Complex untreated coronary artery disease:
- •Unprotected left main coronary artery
- •Syntax score > 32 (in the absence of prior revascularization)
- •Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not excluded.
- •Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying ECHO).
- •Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
- •Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL).
- •Hypertrophic obstructive cardiomyopathy (HOCM).
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
- •Need for emergency surgery for any reason.
- •Severe ventricular dysfunction with LVEF < 20%.
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •Active upper GI bleeding within 3 months (90 days) prior to procedure.
- •A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
- •For patients enrolled in the Native MV arm: Native mitral annulus size < 275 mm2 or > 740 mm2 as measured by CT scan.
- •For patients in Valve-in-Ring arm: surgical ring with a true mean internal diameter ≤18 mm or ≥ 29 mm or an area < 275 mm2 or > 740 mm2 as measured by CT scan. Caution recommended in:
- •Incomplete bands due to risk of paravalvular leak and risk of LVOT obstruction. Careful measurements by CT and CT-guided procedural planning is recommended.
- •Non-circular rigid or semi-flexible rings (e.g., D-shaped, saddle shaped, etc) due to risk of para-valvular leak and/or out of round or incomplete valve expansion.
- •For patients in Valve-in-Valve arm: surgical bioprosthesis with a true internal diameter ≤18 mm or ≥ 29 mm
- •Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
- •Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
- •Expectation that patient will not improve despite treatment of mitral stenosis
- •Active bacterial endocarditis within 6 months (180 days) of procedure.
研究组 & 干预措施
Native mitral valve with severe MAC
Patients with symptomatic severe calcific native mitral valve disease with severe mitral annular calcification who have extremely high surgical risk for standard surgical mitral valve replacement, will undergo transcatheter mitral valve replacement.
干预措施: Transcatheter Mitral Valve Replacement (Device)
Valve-in-Ring
Patients with symptomatic failing surgical rings resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (valve-in-ring).
干预措施: Transcatheter Mitral Valve Replacement (Device)
Valve-in-Valve
Patients with symptomatic failing surgical bioprostheses resulting in severe mitral regurgitation or stenosis will undergo transcatheter mitral valve replacement (Valve-in-valve).
干预措施: Transcatheter Mitral Valve Replacement (Device)
结局指标
主要结局
Mitral Valve Gradient (MVG)
时间窗: 30 days and 1 year
MVG assessed by echocardiography measured in mmHg
Technical Success at Exit From the Cath Lab.
时间窗: 30 days
Number of subject to achieve technical success (at exit from cath lab) is defined as: * Successful vascular delivery and retrieval of transcatheter valve delivery system * Deployment of single valve * Correct position of transcatheter valve * Adequate performance of prosthesis (MVA \> 1.5 cm2) without residual MR grade ≥2 (+) * No need for additional surgery or re-intervention * Patient leaves cath lab alive
Absence of MR Grade 2 (+) or Greater
时间窗: 30 days and 1 year
Number of subjects to have absence of MR grade 2 (+) or greater assessed with echocardiography. MR severity grading system ranging from Grade 1=mild; Grade 4=severe.
次要结局
- Procedural Success(30 days)
研究者
Mayra Guerrero
Principal Investigator
Mayo Clinic