NCT05750173

The EASE-IT CT Registry

Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 75 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Transcatheter Aortic Valve Implantation (TAVI)

Interventions

Type	Name	Description
OTHER	Streamlining of the pre-procedural patient pathway	Pre-TAVI ICA is associated with procedural risk, radiation, costs and requires hospitalization (2d). Show that CTA is a viable alternative to rule out ≥50% left main coronary artery (LM) / prox. left anterior descending artery (LAD) stenosis. An implementation of a standardized patient pathway which is reproducible, will help to streamline the pre-procedural workup of patients without compromising patient safety.

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-03-24
• Completion: 2026-03-24
• First posted: 2023-03-01
• Last updated: 2026-03-30

Locations

6 sites across 2 countries: Austria, Germany