Clinical trial NCT03291925: Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
Official title: Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Aortic Stenosis
Transcatheter Aortic Valve Implantation
Lead sponsor: BC Centre for Improved Cardiovascular Health
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2017-09-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, open-label trial.
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of patients enrolled in the study of all those that are eligible
timeFrame: 18 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 90 days
measure: Myocardial Infarction
timeFrame: Peri-procedural (≤72h post procedure) and 90 days
measure: Unplanned revascularization
timeFrame: 90 days
measure: Bleeding complication
timeFrame: Peri-procedural (≤72h post procedure) and 90 days
measure: Device success
timeFrame: 90 days
measure: Acute Kidney Injury
timeFrame: 90 days
measure: Stroke
timeFrame: 90 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital
name: Jonathon Leipsic, MD
role: PRINCIPAL_INVESTIGATOR
References: