Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Myocardial Infarction
研究概览
简要总结
The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.
Hypothesis
The investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.
详细描述
Primary Objectives:
The primary efficacy objective is to determine whether a Transcatheter Aortic Valve Implantation (TAVI) procedure performed by experienced operators in centers without on-site cardiac surgery is non-inferior to a TAVI procedure performed by experienced operators in centers with on-site cardiac surgery in terms of all-cause death, myocardial infarction, stroke and hospitalization for heart failure. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery (ECS) did not differ between study arms.
Research method/Procedures
ATLAS is an all-comer, prospective, randomized, multicenter, open label trial with blinded adjudicated evaluation of outcomes. The ATLAS study will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI. Participants will be recruited after Heart Team discussion and approval for TAVI. The eligibility of each participant will be confirmed by an established multidisciplinary Heart Team. Once approved for TAVI, dedicated review of the ATLAS study inclusion and exclusion criteria will occur. Study patients meeting inclusion and having no exclusion criteria will be randomized in a 2:1 fashion to TAVI performed in the experimental or standard of care arm stratified by two groups: 1) inoperable/high risk and 2) intermediate/low risk.
Randomization:
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
- Single (Outcomes Assessor)
盲法说明
blinded clinical events adjudicated
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
- •Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team
- •Obtained informed consent
排除标准
- •Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization
- •Hostile aortic root on CT for TAVI implantation defined by, but not limited to:
- •High risk LVOT with a dimension significantly smaller than the annulus and/or extensive calcification
- •Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and/or shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)
- •High risk STJ anatomy defined by inadequate height and/or diameter and/or excessive calcification
- •Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and/or unfolded aorta and/or extensive tortuosity and/or excessive iliofemoral calcification)
- •GFR <15, excluding patients on dialysis
- •Life expectancy less than 3 years
- •Any factor precluding 1-year follow-up
研究组 & 干预措施
Experimental Arm
EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY After randomization, the participant will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff.
干预措施: Transcatheter Aortic Valve Replacement (TAVR) without surgical oversight (Procedure)
Control Arms
CONTROL ARM: TAVI WITH ON-SITE SURGERY After randomization, the patient will be scheduled to undergo TAVI by experienced operators with appropriately trained cardiac catheterization staff at an established TAVI center with on-site cardiac surgery
干预措施: Transcatheter Aortic Valve Replacement (TAVR) with surgical oversight (Procedure)
结局指标
主要结局
Myocardial Infarction
时间窗: From enrolment to the end of 90 day follow up
Primary Efficacy Outcome: Composite of All Cause myocardial infarction (MI) from randomization.
Stroke
时间窗: From enrolment to the end of 90 day follow up
Primary Efficacy Outcome: Composite of All Cause Stroke, from randomization.
Heart Failure Hospitalization
时间窗: From enrolment to the end of 90 day follow up
Primary Efficacy Outcome: Composite of All Cause Heart Failure Hospitalization from randomization.
Occurrence of an Emergent CardiacSurgery (ECS) event: Ventricular
时间窗: From enrolment to the end of 90 day follow up
Primary Safety Outcome: Occurrence of an ECS event: Ventricular Valve Embolization, Aortic Annular Rupture, Ventricular Perforation requiring ECS or Ascending Aortic Dissection requiring ECS. Composite Endpoint of Primary Efficacy and Safety (Net clinical benefit) Multiple measurement will result in an outcome of ECS (Emergent Cardiac Surgery).
Death
时间窗: From enrolment to the end of 90 day follow up
Primary Efficacy Outcome: Composite of All Cause death from randomization.
次要结局
- Procedural wait time(From enrolment to the end of 90 day follow up)
- Minor Bleeding(From enrolment to the end of 90 day follow up)
- Length of hospital stay(From enrolment to the end of 90 day follow up)
- Total days of hospitalization(From enrolment to the end of 90 day follow up)
- Secondary Efficacy Outcomes(From enrolment to the end of 90 day follow up)
- Permanent Pace Maker (PPM)(From enrolment to the end of 90 day follow up)
- Urgent percutaneous coronary revascularization(From enrolment to the end of 90 day follow up)
- Health economics analysis- Healthcare Resource Utilization(From enrolment to the end of 90 day follow up)
- Quality of Life(From enrolment to the end of 90 day follow up)
- Acute kidney injury(From enrolment to the end of 90 day follow up)
- Health economics analysis- Adverse Events(From enrolment to the end of 90 day follow up)
- Health economics analysis- Long-term Outcomes(From enrolment to the end of 90 day follow up)
- Major Bleeding(From enrolment to the end of 90 day follow up)
- Individual components of primary efficacy outcome(From enrolment to the end of 90 day follow up)
- Hospitalization for cardiovascular cause(From enrolment to the end of 90 day follow up)
- Emergent balloon aortic valvuloplasty(From enrolment to the end of 90 day follow up)
- Health economics analysis- Patient-Reported Outcomes (PROs(From enrolment to the end of 90 day follow up)