Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Conditions
Brief summary
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.
Interventions
PROCEDURESelective invasive angiography based on CT/CCTA imaging.
PROCEDUREProcedure/Surgery: Invasive angiography
Sponsors
Edwards Lifesciences
BC Centre for Improved Cardiovascular Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, randomized, open-label trial.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients enrolled in the study of all those that are eligible | 18 months | This is the primary outcome for this pilot study to assess feasibility of a larger trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Infarction | Peri-procedural (≤72h post procedure) and 90 days | According to Valvular Academic Research Consortium-2 (VARC-2) criteria. * Periprocedural MI (≤72h post procedure). * Spontaneous MI. |
| Unplanned revascularization | 90 days | Any unplanned coronary revascularization either with Percutaneous Coronary Intervention( PCI) or Coronary Artery Bypass Graft (CABG) post TAVI procedure. |
| Bleeding complication | Peri-procedural (≤72h post procedure) and 90 days | According to VARC-2 criteria. * TAVI related ≤ 72h post TAVI * Coronary procedure related ≤ 72h post CA or PCI (if staged TAVI-PCI) |
| All-cause mortality | 90 days | — |
| Acute Kidney Injury | 90 days | According to VARC-2 criteria. |
| Stroke | 90 days | 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 |
| Device success | 90 days | According to VARC-2 criteria. |
Countries
Canada
Contacts
Primary ContactShirley Wong, PhD
Outcome results
None listed