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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 self-expandable transfemoral TAVR utilizing the Vancouver 3M Clinical Pathway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancouver Clinical Pathway | Other | Vancouver Clinical Pathway |
|
| 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 Clinical Pathway, who are discharged the next day | Discharge 1 day after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 30 days post-procedure | |
| Stroke | 30 days post-procedure | |
| Major vascular complications |
| Measure | Description | Time Frame |
|---|---|---|
| Death or stroke | 1 year post-procedure |
Inclusion Criteria:
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral TAVR with a self-expanding transcatheter heart valve
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David A Wood, MD | Contact | 6048755601 | david.wood@vch.ca | |
| Shirley C Wong, PhD | Contact | 6046822344 | 65676 | safetavr@icvhealth.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| David A Wood, MD | University of British Columbia | Principal Investigator |
| John A Webb, MD | University of British Columbia | Principal Investigator |
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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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| 30 days post-procedure |
| 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 |
| 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 |
| D014694 |
| Ventricular Outflow Obstruction |