The EASE-IT CT Registry

NCT05750173 | Completed

• 1 other identifier: EASE-IT CT
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Investigational CTA-only cohort

100 consecutive patients that are not already diagnosed with significant (≥50%) proximal stenosis of the left anterior descending artery (LAD) OR the left main coronary artery (LM) and who have not previously undergone coronary revascularisation.

Other: Streamlining of the pre-procedural patient pathway

CTA+ICA control cohort

At least 50 consecutive patients who have not already been diagnosed with significant (≥50%) LM / proximal LAD stenosis an who have not previously undergone conronary 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.

Other: Streamlining of the pre-procedural patient pathway

Interventions

Streamlining of the pre-procedural patient pathway OTHER

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.

CTA+ICA control cohort; Investigational CTA-only cohort

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: collaborator
• Institut für Pharmakologie und Präventive Medizin: lead

Study Sites (6)

Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie

Innsbruck, Tyrol, 6020, Austria

Location

University Clinic St. Pölten

Sankt Pölten, 3100, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Klinik Floridsdorf

Vienna, 1210, Austria

Location

University Hospital Bochum / HDZ NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

University Hospital of the Bergmannsheil gGmbH

Bochum, North Rhine-Westphalia, 44789, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Julia Mascherbauer, Prof. Dr.

  Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: March 1, 2023
• Study Start: September 1, 2023
• Primary Completion: March 24, 2026
• Study Completion: March 24, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); DE (2)