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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancouver 3M Clinical Pathway | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days post-procedure | |
| Stroke | 30 days post-procedure | |
| 30-day major vascular complications |
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Inclusion Criteria:
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a balloon expandable transcatheter heart valve
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Wood, MD | University of British Columbia | Principal Investigator |
| John A Webb, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Paul's Hospital | Vancouver | British Columbia | V6Z1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36256698 | Derived | Butala NM, Wood DA, Li H, Chinnakondepalli K, Lauck SB, Sathananthan J, Cairns JA, Magnuson EA, Barker M, Webb JG, Welsh R, Cheung A, Ye J, Velianou JL, Wijeysundera HC, Asgar A, Kodali S, Thourani VH, Cohen DJ; 3M-TAVR Investigators. Economics of Minimalist Transcatheter Aortic Valve Replacement: Results From the 3M-TAVR Economic Study. Circ Cardiovasc Interv. 2022 Oct;15(10):e012168. doi: 10.1161/CIRCINTERVENTIONS.122.012168. Epub 2022 Oct 18. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019091 | Critical Pathways |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| 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 |
| New permanent pacemaker | 30 days post-procedure |
| Conversion to general anesthetic/intubation | Peri-procedure |
| Myocardial infarction | Peri-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 and SF-12 at baseline, 2 weeks, 30 days, and 1 year | Baseline, and 2 weeks, 30 day and 1 year post procedure |
| Economic evaluation including health resource utilization, and cost effectiveness | Peri- and post-procedure |
| Death or stroke at one year | 1 year post-procedure |
| D014694 |
| Ventricular Outflow Obstruction |