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The EASE-IT CT Registry

Recruiting
75 years of age
Both
Phase N/A

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Overview

ICA is not always required for a pre-TAVI workup of octogenarians and can be substituted by CTA resulting in a streamlined pre-procedural workup of patients without compromising patient safety.

Description

Patients undergoing TAVI require routine pre-procedural assessment of CAD (coronary artery disease).

ICA (invasive coronary angiography) is the gold standard in patients with high pre-test probability. It is associated, however, with procedural risk, radiation and cost.

CTA (computed tomography angiography) currently has limited use for the evaluation of CAD in pts with severe symptomatic AS (aortic stenosis) - medications required such as beta blockers and nitroglycerine, are frequently not well tolerated by pts.

But as TAVI is increasingly being performed in patients with modest pre-test probabilities for obstructive CAD or a lack of implications thereof (pts. ≥75 yrs), the use of CTA may become more appealing.

Eligibility

Inclusion Criteria:

Investigational CTA-only Cohort

  • Consecutive adult patients ≥ 75 years
  • Consecutive patients with severe AS (symptomatic or asymptomatic) with a guideline-based indication to undergo implantation of a transcatheter heart valve of the SAPIEN family
  • Ability to undergo CTA
  • Patient is scheduled to undergo a 30 Day and 3 Months follow-up

CTA+ICA control Cohort

  • Consecutive adult patients ≥ 75 years
  • Consecutive patients underwent implantation of a transcatheter heart valve of the SAPIEN family because of severe aortic stenosis
  • Ability to undergo CTA and ICA

Exclusion Criteria:

investigational CTA-only Cohort

  • Patients with already diagnosed proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50%
  • Any prior coronary revascularization / prior aortic valve replacement
  • Life expectancy below 12 months
  • Lack of informed consent / data protection statement

CTA+ICA control Cohort

  • Patients diagnosed with proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) ≥50% already at baseline
  • Any prior coronary revascularization / prior aortic valve replacement
  • Life expectancy below 12 months
  • Lack of informed consent / data protection statement

Study details

Transcatheter Aortic Valve Implantation (TAVI)

NCT05750173

Institut für Pharmakologie und Präventive Medizin

27 April 2025

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