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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective invasive angiography based on CT/CCTA imaging | Experimental | Patients will undergo selective invasive angiography based on CT/CCTA imaging. Decision to procede with additional invasive CA will be based on adequacy of CT/CCTA evaluation and likelihood of significant coronary artery disease. |
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| Invasive Cardiac Angiography | Active Comparator | Patients will undergo systematic invasive angiography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective invasive angiography based on CT/CCTA imaging. | Procedure |
| ||
| Procedure/Surgery: Invasive angiography |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients enrolled in the study of all those that are eligible | This is the primary outcome for this pilot study to assess feasibility of a larger trial. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 90 days | |
| Myocardial Infarction | According to Valvular Academic Research Consortium-2 (VARC-2) criteria.
| Peri-procedural (≤72h post procedure) and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley Wong, PhD | Contact | 604-682-2344 | 3M@icvhealth.ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathon Leipsic, MD | St. Paul's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z1Y6 | Canada |
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Prospective, randomized, open-label trial.
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| Procedure |
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| Unplanned revascularization | Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure. | 90 days |
| Bleeding complication | According to VARC-2 criteria.
| Peri-procedural (≤72h post procedure) and 90 days |
| Device success | According to VARC-2 criteria. | 90 days |
| Acute Kidney Injury | According to VARC-2 criteria. | 90 days |
| Stroke | An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as assessed by a clinician and confirmed by at least one cerebral imaging study (CT or MRI). Stroke may be classified as ischaemic or haemorrhagic | 90 days |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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