TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 657
- 试验地点
- 14
- 主要终点
- Primary safety endpoint
研究概览
简要总结
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.
详细描述
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.
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
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE)
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 aortic stenosis
- •Indication to TAVI confirmed by the Study Heart Team
- •AND one of the following:
- •Inoperable due to prohibitive operative risk
- •High surgical risk as defined as STS score >8%
- •The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
- •Porcelain aorta or severely atherosclerotic aorta
- •Frailty/Reduced physical performance
- •Cognitive impairment, dementia, or Parkinson's disease
- •Severe liver disease/cirrhosis
- •Hostile chest
- •Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
- •Severe pulmonary hypertension and/or severe right ventricular dysfunction
- •Severe Chronic Obstructive Pulmonary Disease (COPD)
- •Age ≥85 years
排除标准
- •Unsuitable for transfemoral TAVI
- •Emergent TAVI
- •Noncardiovascular comorbidity reducing life expectancy to <1 year
- •Any factor precluding 1-year follow-up
- •Refusal informed consent
研究组 & 干预措施
EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI in their hospital without on-site surgery
干预措施: TAVI WITHOUT ON-SITE SURGERY (Procedure)
CONTROL ARM: TAVI WITH ON-SITE SURGERY
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
干预措施: TAVI WITH ON-SITE SURGERY (Procedure)
结局指标
主要结局
Primary safety endpoint
时间窗: 1-year
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
Primary efficacy endpoint
时间窗: 1-year
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
次要结局
- Secondary efficacy endpoints(1-year)
- Other safety endpoints(1-year)