Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI

Study Overview
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Brief Summary
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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.

Official Title
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Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)

Conditions
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Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation

Intervention / Treatment
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* Procedure: Selective invasive angiography based on CT/CCTA imaging.
* Procedure: Procedure/Surgery: Invasive angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of < 1.0cm2) Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina) Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon) Exclusion Criteria: Severe renal dysfunction Glomerular filtration rate < 30 ml/min. Severe left ventricular dysfunction LVEF ≤ 30% Recent coronary angiography ≤ 6months from randomization Recent PCI ≤ 6months from randomization Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, open-label trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective invasive angiography based on CT/CCTA imaging<br>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. | Procedure: Selective invasive angiography based on CT/CCTA imaging.<br> <br> |
| Active Comparator: Invasive Cardiac Angiography<br>Patients will undergo systematic invasive angiography. | Procedure: Procedure/Surgery: Invasive angiography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 90 days | 
| Myocardial Infarction | According to Valvular Academic Research Consortium-2 (VARC-2) criteria. Periprocedural MI (≤72h post procedure). Spontaneous MI. | Peri-procedural (≤72h post procedure) and 90 days | 
| 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. TAVI related ≤ 72h post TAVI Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI) | 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 |