The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction
研究概览
简要总结
Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers
详细描述
Anonymized pre-, intra-, and postoperative data will be collected from patients undergoing VinV TAVI in a previously implanted Trifecta™ valve, Trifecta™ GT, Epic™ or Epic™ Supra valve from the largest volume implanters of the Trifecta and Epic valve in Europe until June 2020. The data will be analyzed in order to give a comprehensive description of clinical outcomes for Trifecta VinV procedures, to identify preoperative risk factors for coronary obstruction, 30-day and 1-year mortality, and other major complications, and to analyze the effects of patient characteristics and / or protective maneuvers in order to prevent coronary obstruction.
Differences of Trifecta and Epic failed patients will also be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent a TAVI VinV procedure post-Trifecta or Epic implantation
- •Patients who underwent planned or unplanned concomitant percutaneous coronary intervention (PCI) during the index hospital admission will be included, as will those undergoing emergent conventional cardiac surgery.
排除标准
- •TAVI VinV post-implantation of an aortic valve bioprosthesis other than the Trifecta or Epic valve
- •Patients undergoing combined, multiple transcatheter valve procedures in addition to TAVI VinV
结局指标
主要结局
composite endpoint of 30-day all-cause mortality and/or unplanned coronary obstruction
时间窗: 30 days
coronary obstruction defined as (1) coronary obstruction resulting in myocardial infarction and/or cardiogenic shock, or (2) coronary obstruction requiring emergent coronary intervention with or without pre-TAVI coronary protection.
次要结局
- patients with unplanned coronary obstruction(30-days)
- freedom from Major Adverse Cardiac Events defined as death, myocardial infarction or stroke(up to 60 months)
- freedom from each individual Major Adverse Cardiac Event endpoint(up to 60 months)
- all-cause mortality(30-days)
- freedom from other major Valve Academic Research Consortium 2 (VARC2) complications(day of discharge from hospital after receiving VinV TAVI or 30 days, whichever is earlier)
- freedom from other major VARC2 complications(up to 60 months)
- post-VinV hemodynamic performance including transvalvular gradient, effective orifice area and paravalvular leak rate(up to 60 months)