Status:
UNKNOWN
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
Lead Sponsor:
BC Centre for Improved Cardiovascular Health
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Severe Aortic Stenosis
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
Phase:
NA
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) strateg...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03291925
Start Date
November 1 2016
End Date
September 1 2019
Last Update
September 25 2017
Active Locations (1)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6