Brief Title
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)
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.
Study Type
Interventional
Primary Outcome
Number of patients enrolled in the study of all those that are eligible
Secondary Outcome
All-cause mortality
Condition
Severe Aortic Stenosis
Intervention
Selective invasive angiography based on CT/CCTA imaging.
Study Arms / Comparison Groups
Selective invasive angiography based on CT/CCTA imaging
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
November 2016
Completion Date
September 2019
Primary Completion Date
September 2019
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).
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Jonathon Leipsic, MD, 604-682-2344, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03291925
Organization ID
ICVHealth2016002
Responsible Party
Sponsor
Study Sponsor
BC Centre for Improved Cardiovascular Health
Collaborators
Edwards Lifesciences
Study Sponsor
Jonathon Leipsic, MD, Principal Investigator, St. Paul's Hospital
Verification Date
September 2017