Transcatheter Aortic Valve Implantation (TAVI)NCT05750173
The EASE-IT CT Registry
An observational study of Transcatheter Aortic Valve Implantation (TAVI), run by Institut für Pharmakologie und Präventive Medizin at 6 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation (TAVI)
- What is being tested?
- Streamlining of the pre-procedural patient pathway
- How many people
- 150 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Sep 2023to 24 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Austria4 sites
Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie
Innsbruck, Tyrol, 6020
University Clinic St. Pölten
Sankt Pölten, 3100
Medical University of Vienna
Vienna, 1090
Klinik Floridsdorf
Vienna, 1210
Germany2 sites
University Hospital Bochum / HDZ NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
University Hospital of the Bergmannsheil gGmbH
Bochum, North Rhine-Westphalia, 44789
About this study
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
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.
Read the 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.
- Being tested
- Streamlining of the pre-procedural patient pathway
- Keywords
- TAVI, Transcatheter Aortic Valve Implantation, severe Aortic Stenosis, sAS, computed tomography angiography, CTA, invasive coronary angiography, ICA, Coronary Artery Disease, CAD
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streamlining of the pre-procedural patient pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Streamlining of the pre-procedural patient pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Sep 2023
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Implantation (TAVI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Julia Mascherbauer, Prof. Dr., Principal investigator, Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750173
- Sponsor's protocol ID
- EASE-IT CT
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data (IPD) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05750173
- Acronym / sponsor ID
- EASE-IT CT
- Keywords
- TAVI, Transcatheter Aortic Valve Implantation, severe Aortic Stenosis, sAS, computed tomography angiography, CTA, invasive coronary angiography, ICA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational CTA-only cohort | – | Other: Streamlining of the pre-procedural patient pathway100 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. |
| CTA+ICA control cohort | – | Other: Streamlining of the pre-procedural patient pathwayAt 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streamlining of the pre-procedural patient pathwayPre-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. | Other | CTA+ICA control cohort, Investigational CTA-only cohort |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No. no individual participant data (IPD) will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Mascherbauer, Prof. Dr. principal investigator
Clinical Department for Internal Medicine 3, University Hospital St. Pölten, Austria
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation (TAVI), run by Institut für Pharmakologie und Präventive Medizin at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Number and percentage of patients experiencing CAD specific outcomes in each group at 30 days after TAVI (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.