Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients Who Have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,500
- 试验地点
- 178
- 主要终点
- Composite of all-cause mortality or all stroke
研究概览
简要总结
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.
In addition, the trial will assess the safety of the Navitor TAVI System for the treatment of symptomatic, severe native aortic stenosis in patients with bicuspid aortic valve anatomy, irrespective of surgical risk classification.
详细描述
ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort.
The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
The Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio.
The ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV).
The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.
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
- •Subject who is deemed to be at intermediate or low risk for open surgical aortic valve replacement:
- •Intermediate risk: estimated risk of overall surgical mortality ≥ 3% and < 8% at 30 days
- •Low risk: estimated risk of overall surgical mortality < 3% at 30 days Estimated risk of overall surgical mortality includes consideration of the Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical co-morbidities unmeasured by the risk calculator
- •New York Heart Association (NYHA) Functional Classification of II, III, or IV
- •Degenerative aortic valve stenosis
排除标准
- •In the opinion of the Investigator, life expectancy is less than 2 years
- •Evidence of an acute myocardial infarction [defined as ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) with acute ischemia symptoms and troponin elevation] within 30 days prior to index procedure
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior (except pacemaker or implantable cardioverter defibrillator (ICD) implant) to index procedure or planned within 30 days following the index procedure
- •Blood dyscrasias as defined: leukopenia (WBC < 3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mm³); history of bleeding diathesis or coagulopathy
- •Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
- •Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
- •Renal insufficiency (creatinine > 3.0 mg/dL or eGFR < 30 ml/min/1.73m2) and/or end stage renal disease requiring chronic dialysis
- •Hostile chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk (i.e., mediastinitis, radiation damage, abnormal chest wall, porcelain aorta, adhesion of aorta or internal mammary artery to sternum, etc.)
- •Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)
- •Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT.
- •Severe ventricular dysfunction with LVEF < 30% as measured by resting echocardiogram
- •Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
- •Severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the left ventricular outflow tract (LVOT)
- •Severe (greater than or equal to 3+) mitral regurgitation or severe mitral stenosis
- •Minimum access vessel diameter of < 5.0 mm for small FlexNav Delivery System and < 5.5 mm for large FlexNav Delivery System
- •Eccentricity ratio of the annulus < 0.73
- •Additional Exclusion Criteria for Pivotal Randomized Cohort
- •Hostile Chest or conditions or complications from prior surgery that would make the subject be considered high surgical risk
- •Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
- •Mixed aortic valve disease
- •Aortic valve is a unicuspid or bicuspid valve as verified by echocardiography or CT
- •Inadequate aortic valve calcification
- •Pre-existing prosthetic heart valve or other implant (such as prosthetic ring or transcatheter edge-to-edge repair (TEER) clip) in any valve position
- •Additional Exclusion Criteria for ViV Cohort
- •Failing valve has moderate or greater paravalvular regurgitation.
- •Known severe prosthesis-patient mismatch
- •Failing valve is unstable, rocking, or not structurally intact.
- •Patient has a pre-existing prosthetic heart valve or other implant (such a prosthetic ring with a rigid support structure or transcatheter edge-to-edge repair clip) in any valve position other than aortic.
- •Bioprosthetic valve diameter that would not accommodate implantation of the Navitor Valve.
- •Increased risk of coronary obstruction by prosthetic leaflets of the index valve
- •Additional Exclusion Criteria for bicuspid cohort
- •In the opinion of the Investigator life expectancy is less than 1 year
- •Inadequate or severe aortic valve calcification and/or anatomical features that would preclude safe delivery of the valve
研究组 & 干预措施
Any Commercially Available Transcatheter Aortic Valve System (CAV)
TAVI with any FDA approved commercially available Transcatheter Aortic Valve System (CAV)
干预措施: Any Commercially Available Transcatheter Aortic Valve (CAV) System (Device)
Navitor Transcatheter Aortic Valve Implantation (TAVI) System
TAVI with Abbott Navitor Transcatheter Aortic Valve Implantation (TAVI) System
干预措施: Navitor Transcatheter Aortic Valve Implantation (TAVI) System (Device)
结局指标
主要结局
Composite of all-cause mortality or all stroke
时间窗: At 12 months post-procedure
Number of patients that had any of the outcome events.
次要结局
未报告次要终点