NCT03291925

Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI

Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI: A Randomized Controlled Pilot Trial (CT-CA Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: BC Centre for Improved Cardiovascular Health · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Aortic Stenosis
• Transcatheter Aortic Valve Implantation

Interventions

Type	Name	Description
PROCEDURE	Selective invasive angiography based on CT/CCTA imaging.
PROCEDURE	Procedure/Surgery: Invasive angiography

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-09-25
• Last updated: 2017-09-25

Locations

1 site across 1 country: Canada