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Completed

NCT Number: NCT05750173

The EASE-IT CT Registry

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.

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Key information

Conditions

Transcatheter Aortic Valve Implantation (TAVI) Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases Ventricular Outflow Obstruction

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie, Innsbruck, Tyrol, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI

    Time frame: 30 days

    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

  2. Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 3 months after TAVI

    Time frame: 3 months

    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. Number and percentage of patients with Device success assessed at 30 days after TAVI using the VARC3 criteria

    Time frame: 30 days

    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.

  4. Number and percentage of patients free from Device safety issues assessed at 30 days after TAVI using the VARC3 criteria

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 1, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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