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

NCT03291925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-09-25

No results posted yet for this study

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

PROCEDURE

Selective invasive angiography based on CT/CCTA imaging.

PROCEDURE

Procedure/Surgery: Invasive angiography

Sponsors & Collaborators

  • Edwards Lifesciences

    collaborator INDUSTRY

  • BC Centre for Improved Cardiovascular Health

    lead OTHER

Principal Investigators

  • Jonathon Leipsic, MD · St. Paul's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03291925 on ClinicalTrials.gov