NCT03600935Unknown不适用
Safety and Feasibility of Early Discharge Using the Portico Self-Expanding Prosthesis for Transfemoral Transcatheter Aortic Valve Replacement: The SAFE TAVR Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 315
- 主要终点
- The composite of all-cause mortality or stroke
研究概览
简要总结
The primary objective of this study is to determine the efficacy, safety and feasibility of next day discharge home in patients undergoing self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
- •Considered at increased surgical risk by the Multidisciplinary Heart Team
- •Informed written consent
排除标准
- •Non-cardiovascular co-morbidity reducing life expectancy to <3 years
- •Any factor precluding 1 year follow-up
- •Inadequate CT image acquisition to perform area-based annular CT sizing, exclude adverse root features, and determine a coaxial valve deployment angle (CT is not required for valve-in-valve procedures)
- •Predicted inability to perform uncomplicated percutaneous vascular access and closure
- •Illiofemoral diameter <6 mm (for 23 and 25 mm valves) and <6.5 mm (for 27 and 29 mm valves) measured at or below the femoral head
- •Surgical prosthesis <23 mm (labelled size) for valve-in-valve procedure
- •In-patient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons)
- •Language barriers (inability to understand peri-procedural and discharge instructions)
- •Insufficient social support post procedure to allow next day discharge
- •Airway unfavourable for emergent intubation
- •Inability to lay supine without conscious sedation or general anaesthetic
研究组 & 干预措施
Vancouver Clinical Pathway
Experimental
The Vancouver Clinical Pathway utilizes objective anatomical and functional screening criteria as well as strict peri-procedural guidelines to determine if next day discharge home is appropriate.
干预措施: Vancouver Clinical Pathway (Other)
结局指标
主要结局
The composite of all-cause mortality or stroke
时间窗: 30 days post-procedure
The proportion of patients undergoing elective transfemoral TAVR using the Vancouver Clinical Pathway, who are discharged the next day
时间窗: Discharge 1 day after procedure
次要结局
- Major/Life-threatening bleed(30 days post-procedure)
- Any hospital readmission(30 days post-procedure)
- >mild paravalvular regurgiation(Immediately after a procedure is performed or at time immediately prior to discharge, up to 48 hours after procedure)
- All-cause mortality(30 days post-procedure)
- Stroke(30 days post-procedure)
- Major vascular complications(30 days post-procedure)
- New permanent pacemaker(30 days post-procedure)
- Patient is converted from local to general anaesthetic/receives intubation during procedure(This happens during the procedure)
- Myocardial infarction(This happens during the procedure)
- Repeat procedure for valve-related dysfunction(30 days post-procedure)
- Stage 3 acute kidney injury (need for dialysis)(30 days post-procedure)
- Patient-centred outcomes including health related quality of life as measured by KCCQ at baseline, 30 days and 1 year(Baseline, and 30 days and 1 year post-procedure)
研究者
相似试验
Unknown
不适用
Safety of Early Discharge Following Low Risk Myocardial InfarctionMyocardial InfarctionNCT01868256Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1,558
已完成
不适用
Safety And Feasibility of Early DischargE - a Prospective And Randomized Trial of Low-risk Primary Percutaneous Coronary Intervention (PCI) PatientsMyocardial InfarctionNCT00474214Hamilton Health Sciences Corporation54
Unknown
不适用
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung SurgerySurgeryLung CancerNCT05583916McGill University Health Centre/Research Institute of the McGill University Health Centre20
已完成
不适用
Verification of the Safety of Early Discharge in Patients After Acute ST-segment Myocardial InfarctionAcute Myocardial Infarction With ST-segment ElevationPrimary Percutaneous Coronary InterventionEarly DischargeCoronary Artery DiseaseNCT02023983Kamil Novobílský151
已完成
不适用
Safety of Same Day Discharge After Elective Percutaneous Coronary InterventionAngioplastyCoronaryNCT02214082Indus Hospital and Health Network210