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
- 2
- 主要终点
- The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day
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 proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day
时间窗: Next day
The composite of all-cause mortality or stroke
时间窗: 30 days post-procedure
次要结局
- 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)
- 30-day major/life-threatening bleed(30 days post-procedure)
- New permanent pacemaker(30 days post-procedure)
- Any readmission to hospital within 30 days(30 days post-procedure)
- > mild paravalvular regurgitation(Post-procedure/discharge)
- Conversion to general anesthetic/intubation(Peri-procedure)
- 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 (2)
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