NCT02287662已完成不适用
The Vancouver Multidisciplinary, Multimodality, But Minimalist Clinical Pathway Facilitates Safe Next Day Discharge Home at Low, Medium, and High Volume Transfemoral Transcatheter Aortic Valve Replacement Centres: The 3M TAVR Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 1
- 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 balloon-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway in low, medium, and high volume North American centres.
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 balloon expandable 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
- •Iliofemoral diameter < 6 mm for SAPIEN XT or <5.5 mm for SAPIEN 3 (measured at or above the mid-femoral head)
- •Inpatient (unless clinically stable, mobilizing at baseline, and primarily in hospital for logistical reasons.
- •Significant communication barrier(s) that interfere with ability to follow peri-procedural and discharge instructions
- •MMSE < 24/30 (unless language barrier or limited formal education), 5-metre gait > 7 seconds (unless chronic mobility impairment not affecting ability to perform ADLs), and ADL < 6/6
- •Insufficient social support to facilitate next day discharge
- •Airway unfavourable for emergent intubation
- •Inability to lay supine without conscious sedation or general anesthetic
- •Not receiving a balloon expandable transcatheter heart valve
研究组 & 干预措施
Vancouver 3M Clinical Pathway
Experimental
The Vancouver 3M 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 3M 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 3M Clinical Pathway, who are discharged the next day
时间窗: Next day
次要结局
- Conversion to general anesthetic/intubation(Peri-procedure)
- Any readmission to hospital within 30 days(30 days post-procedure)
- Stage 3 acute kidney injury (need for dialysis)(30 days post-procedure)
- Stroke(30 days post-procedure)
- 30-day major vascular complications(30 days post-procedure)
- Myocardial infarction(Peri-procedure)
- All-cause mortality(30 days post-procedure)
- New permanent pacemaker(30 days post-procedure)
- 30-day major/life-threatening bleed(30 days post-procedure)
- > mild paravalvular regurgitation(Post-procedure/discharge)
- Patient-centred outcomes including health related quality of life as measured by KCCQ and SF-12 at baseline, 2 weeks, 30 days, and 1 year(Baseline, and 2 weeks, 30 day and 1 year post procedure)
- Death or stroke at one year(1 year post-procedure)
- Repeat procedure for valve-related dysfunction(30 days post-procedure)
- Economic evaluation including health resource utilization, and cost effectiveness(Peri- and post-procedure)
研究者
研究点 (1)
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