Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI (CT-CA)

BC Centre for Improved Cardiovascular Health

Status: Unknown

Conditions: Transcatheter Aortic Valve Implantation; Severe Aortic Stenosis

Treatments: Procedure: Procedure/Surgery: Invasive angiography; Procedure: Selective invasive angiography based on CT/CCTA imaging.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03291925

ICVHealth2016002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Selective invasive angiography based on CT/CCTA imaging

Experimental group

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.

Treatment:

Procedure: Selective invasive angiography based on CT/CCTA imaging.

Invasive Cardiac Angiography

Active Comparator group

Description:

Patients will undergo systematic invasive angiography.

Treatment:

Procedure: Procedure/Surgery: Invasive angiography