The EASE-IT CT Registry

Transcatheter Aortic Valve Implantation (TAVI) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750173
• Other study ID #: EASE-IT CT
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: Claudia Lüske, PhD
• Phone: 044718503324
• Email: claudia.lueske[@]ippmed.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 31, 2025
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 75 Years and older

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Transcatheter Aortic Valve Implantation (TAVI)

Intervention

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.

Locations

Country	Name	City	State
Austria	University Clinic St. Pölten	St. Pölten
Austria	Medical University of Vienna	Vienna
Germany	University Hospital Bochum / HDZ NRW	Bad Oeynhausen	NRW
Germany	University Hospital of the Bergmannsheil gGmbH	Bochum	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI	CAD specific combined "endpoint" at 30 days; All-cause death; Non-fatal myocardial infarction; Ischemia-driven revascularization; Rehospitalization (valve- or procedure-related including heart failure); Life-threatening/disabling or major bleeding; Number and percentage of subjects with above specified outcomes at 30 days	30 days
Primary	Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI	CAD specific combined "endpoint" at 3 months; All-cause death; Non-fatal myocardial infarction; Ischemia-driven revascularization; Rehospitalization (valve- or procedure-related including heart failure); Life-threatening/disabling or major bleeding; Number and percentage of subjects with above specified outcomes at 3 months.	3 months
Primary	Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria	VARC-3 defined device success at 30 days: Technical success; Freedom from mortality; Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication; Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index =0.25, and less than moderate aortic regurgitation); Number and percentage of subjects with device success at 30 days as per VARC-3 definition.	30 days
Primary	Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria	VARC-3 defined early safety at 30 days: Freedom from all-cause mortality; Freedom from all Stroke; Freedom from all VARC type 2-4 bleeding; Freedom from all major vascular, access-related, or cardiac structural complication; Freedom from all acute kidney injury stage III/IV; Freedom from all moderate/severe aortic regurgitation; Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities; Freedom from all surgery/intervention related to the device; Number and percentage of subjects free from VARC3-defined safety issues at 30 days as per VARC-3 definition.	30 days