The Multidisciplinary, Multimodality, But Minimalist Approach to Transfemoral Transcatheter Aortic Valve Replacement
Not Applicable
Completed
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: Vancouver 3M Clinical Pathway
- Registration Number
- NCT02287662
- Lead Sponsor
- BC Centre for Improved Cardiovascular Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 411
Inclusion Criteria
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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vancouver 3M Clinical Pathway Vancouver 3M Clinical Pathway 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.
- Primary Outcome Measures
Name Time Method The composite of all-cause mortality or stroke 30 days post-procedure The proportion of patients undergoing elective transfemoral TAVR using the Vancouver 3M Clinical Pathway, who are discharged the next day Next day
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada