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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.
Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease).
ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost.
CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts.
But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational CTA-only cohort | 100 consecutive patients that are not already diagnosed with significant (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) and who have not previously undergone coronary revascularisation. |
| |
| CTA+ICA control cohort | At least 50 consecutive patients who have not already been diagnosed with significant (≥50%) LM / proximal LAD stenosis an who have not previously undergone conronary revascularisation and will undergo CTA. If LM / proximal LAD stenosis of ≥50% can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Streamlining of the pre-procedural patient pathway | Other | Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI | CAD specific combined "endpoint" at 30 days
Number and percentage of subjects with above specified outcomes at 30 days | 30 days |
| Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI | CAD specific combined "endpoint" at 3 months
Number and percentage of subjects with above specified outcomes at 3 months. | 3 months |
| Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria | VARC-3 defined device success at 30 days:
Number and percentage of subjects with device success at 30 days as per VARC-3 definition. | 30 days |
| Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria | VARC-3 defined early safety at 30 days:
Number and percentage of subjects free from VARC3-defined safety issues at 30 days as per VARC-3 definition. |
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Inclusion Criteria:
Investigational CTA-only Cohort
CTA+ICA control Cohort
Exclusion Criteria:
investigational CTA-only Cohort
CTA+ICA control Cohort
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Investigational CTA-only phase:
100 consecutive patient who have not already been diagnosed with significant (≥50%) left main coronary artery (LM) or proximal stenosis of the left anterior descending artery (LAD) ans who have not previously undergone coronary revascularisation.
CTA+ICA control phase:
50 consecutive patients who have not alreeady been diagnosed with significant (≥50%) left main coronary artery (LM) / proximal LAD stenosis and who have not previously undergone coronary revascularisation and will undergo CTA. If LM/ proximal LAD stenosis of (≥50%) can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group.
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| Name | Affiliation | Role |
|---|---|---|
| Julia Mascherbauer, Prof. Dr. | Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie | Innsbruck | Tyrol | 6020 | Austria | ||
no individual participant data (IPD) will be shared
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 30 days |
| University Clinic St. Pölten |
| Sankt Pölten |
| 3100 |
| Austria |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Klinik Floridsdorf | Vienna | 1210 | Austria |
| University Hospital Bochum / HDZ NRW | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
| University Hospital of the Bergmannsheil gGmbH | Bochum | North Rhine-Westphalia | 44789 | Germany |
| D014694 |
| Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |