Clinical trial NCT05750173: The EASE-IT CT Registry
Official title: Pre-procedural Assessment of Coronary Artery Disease in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI) - Comparision of Pre-TAVI CTA vs. Pre-TAVI ICA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transcatheter Aortic Valve Implantation (TAVI)
Keywords: TAVI
Transcatheter Aortic Valve Implantation
severe Aortic Stenosis
sAS
computed tomography angiography
CTA
invasive coronary angiography
ICA
Coronary Artery Disease
CAD
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Edwards Lifesciences
First posted: 2023-03-01
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigational CTA-only phase:

100 consecutive patient who have not already been diagnosed with significant (≥50%) left main coronary artery (LM) or proximal stenosis of the left anterior descending artery (LAD) ans who have not previously undergone coronary revascularisation.

CTA+ICA control phase:

50 consecutive patients who have not alreeady been diagnosed with significant (≥50%) left main coronary artery (LM) / proximal LAD stenosis and who have not previously undergone coronary revascularisation and will undergo CTA. If LM/ proximal LAD stenosis of (≥50%) can be ruled out and ICA is also performed prior to TAVI these patients will serve as control group.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI
timeFrame: 30 days
measure: Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI
timeFrame: 3 months
measure: Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria
timeFrame: 30 days
measure: Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie
state: Tirol
city: St. Pölten
country: Austria
facility: University Clinic St. Pölten
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Bad Oeynhausen
country: Germany
facility: University Hospital Bochum / HDZ NRW
state: NRW
city: Bochum
country: Germany
facility: University Hospital of the Bergmannsheil gGmbH
state: NRW
Study officials:
affiliation: Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria
name: Julia Mascherbauer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: