Severe Aortic StenosisNCT07813273
Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry
An observational study of Severe Aortic Stenosis, run by Yonsei University.
Trial summary
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart valve in patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Aortic Stenosis
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2026to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.
Who may be able to join
- Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.
- Age ≥65 years.
- Ability and willingness to provide written informed consent for participation in the study.
Who cannot join
- Inability to undergo contrast-enhanced cardiac CT before TAVI.
- Anomalous origin of a coronary artery.
- Bicuspid aortic valve.
- Previous surgical or transcatheter aortic valve replacement.
- Cardiogenic shock or hemodynamic instability.
- Chronic kidney disease stage 3b, 4, or 5, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m².
- Thrombocytopenia (platelet count <100,000/μL) or an increased bleeding risk precluding antiplatelet or anticoagulant therapy.
- Allergy or hypersensitivity to aspirin or clopidogrel precluding antiplatelet therapy in patients without an indication for oral anticoagulation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart valve in patients with severe aortic stenosis.
TAVI has become an established treatment for patients with severe aortic stenosis across a broad range of surgical risk profiles. As TAVI is increasingly performed in younger patients with longer life expectancy, maintaining access to the coronary arteries after transcatheter heart valve implantation has become an important clinical consideration. A substantial proportion of patients undergoing TAVI have concomitant coronary artery disease and may subsequently require coronary angiography or percutaneous coronary intervention. However, coronary access after TAVI may be challenging because of the spatial relationship between the transcatheter heart valve frame, commissural posts, valve leaflets, and coronary ostia.
Read more
Commissural alignment between the native aortic valve and the implanted transcatheter heart valve may play an important role in preserving coronary access. Commissural misalignment may result in a commissural post or valve leaflet being positioned in front of a coronary ostium, potentially interfering with subsequent selective coronary cannulation. In addition to commissural alignment, the geometry and orientation of the transcatheter valve frame relative to the coronary ostia may influence the feasibility of coronary re-access.
The Evolut FX Plus transcatheter heart valve incorporates three enlarged frame cells designed to facilitate coronary access. This modification is intended to increase the likelihood that at least one large cell is favorably positioned relative to each coronary ostium. However, prospective data evaluating selective coronary cannulation through these large cells and the relationship between large-cell orientation, commissural alignment, and coronary anatomy in clinical practice remain limited.
The study will enroll approximately 122 patients aged 65 years or older with severe aortic stenosis undergoing TAVI with the Evolut FX Plus valve. Immediately after valve implantation, selective cannulation of the left and right coronary arteries through the large-cell frame will be attempted using standard diagnostic coronary catheters. The primary endpoint is the successful selective coronary cannulation rate through the Evolut FX Plus large-cell frame, assessed separately for the left and right coronary arteries. Successful selective coronary cannulation is defined as stable engagement of a diagnostic catheter at the coronary ostium allowing coronary contrast injection.
Cardiac computed tomography (CT) performed 3 to 6 months after TAVI will provide a detailed assessment of the spatial relationship between the implanted transcatheter heart valve and the coronary ostia. CT-based assessments will include large cell-to-coronary alignment, alignment between the center of the transcatheter valve leaflet and the coronary ostium, and commissural alignment between the native and transcatheter aortic valves. Follow-up CT will also be used to evaluate findings of valve thrombosis, including leaflet, supravalvular, subvalvular, and sinus hypoattenuation.
Read the detailed description
TAVI will be performed according to standard clinical practice. A commissural alignment technique will be used during valve implantation, with appropriate orientation of the delivery system and fluoroscopic assessment during valve deployment.
Immediately after valve implantation, selective coronary cannulation of the left coronary artery and right coronary artery through the Evolut FX Plus large-cell frame will be attempted using standard diagnostic coronary catheters. The primary endpoint is the successful selective coronary cannulation rate through the large-cell frame, assessed separately for the left and right coronary arteries. Successful selective coronary cannulation is defined as stable engagement of the diagnostic catheter at the coronary ostium allowing coronary contrast injection.
Cardiac CT performed 3 to 6 months after TAVI will be analyzed to assess the spatial relationship between the implanted valve and the coronary ostia. CT-based assessments will include large cell-to-coronary alignment, alignment between the center of the transcatheter valve leaflet and the coronary ostium, commissural alignment between the native and transcatheter aortic valves, and findings of valve thrombosis, including leaflet, supravalvular, subvalvular, and sinus hypoattenuation.
Clinical efficacy and safety outcomes will be assessed at 30 days and 6 months. Clinical events will be defined according to Valve Academic Research Consortium-3 (VARC-3) criteria where applicable.
- Conditions
- Severe Aortic Stenosis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing TAVI using Evolut FX Plus | Patients aged 65 years or older with severe aortic stenosis who are scheduled to undergo TAVI with the Evolut FX Plus transcatheter heart valve and who meet all eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Selective Coronary Cannulation Through the Evolut FX Plus Large-Cell Frame
The proportion of patients in whom successful selective coronary cannulation is achieved through the Evolut FX Plus large-cell frame, assessed separately for the left coronary artery and right coronary artery. Successful selective coronary cannulation is defined as stable engagement of a standard diagnostic catheter at the coronary ostium allowing coronary contrast injection.
Measured: Day 0 (Immediately after Evolut FX Plus implantation)
Secondary outcomes (6)
Technical Success
Technical success following TAVI with the Evolut FX Plus valve, assessed according to the study protocol and applicable VARC-3 criteria.
Measured: 30 days after TAVI
Devicel Success
Device success following TAVI with the Evolut FX Plus valve, assessed according to the study protocol and applicable VARC-3 criteria.
Measured: 30 days after TAVI
Clinical outcomes (Composite of All-Cause Mortality, All Stroke, or Procedure- or Valve-Related Hospitalization)
Composite of All-Cause Mortality, All Stroke, or Procedure- or Valve-Related Hospitalization
Measured: 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Large Cell-to-Coronary Misalignment)
- Moderate or Greater Large Cell-to-Coronary Misalignment:: Proportion of patients with moderate or severe large cell-to-coronary misalignment on follow-up cardiac CT. Alignment is determined by the angle between the center of the large cell and the center of the coronary ostium.
Measured: 3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Leaflet Center-to-Coronary Misalignment)
- Moderate or Greater Leaflet Center-to-Coronary Misalignment: Proportion of patients with moderate or severe misalignment between the center axis of the transcatheter valve leaflet and the center of the coronary ostium on follow-up cardiac CT.
- Moderate or Greater Commissural Misalignment
Measured: 3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Commissural Misalignment)
Moderate or Greater Commissural Misalignment::
Proportion of patients with moderate or severe commissural misalignment between the native aortic valve commissures and the transcatheter heart valve commissures on follow-up cardiac CT.
Measured: 3 to 6 months after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start29 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813273
- Sponsor's protocol ID
- 1-2026-0038
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry
- ClinicalTrials.gov ID
- NCT07813273
- Acronym / sponsor ID
- 1-2026-0038
- Conditions
- Severe Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 10 Sep 2026 (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.
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart valve in patients with severe aortic stenosis.
TAVI has become an established treatment for patients with severe aortic stenosis across a broad range of surgical risk profiles. As TAVI is increasingly performed in younger patients with longer life expectancy, maintaining access to the coronary arteries after transcatheter heart valve implantation has become an important clinical consideration. A substantial proportion of patients undergoing TAVI have concomitant coronary artery disease and may subsequently require coronary angiography or percutaneous coronary intervention. However, coronary access after TAVI may be challenging because of the spatial relationship between the transcatheter heart valve frame, commissural posts, valve leaflets, and coronary ostia.
Commissural alignment between the native aortic valve and the implanted transcatheter heart valve may play an important role in preserving coronary access. Commissural misalignment may result in a commissural post or valve leaflet being positioned in front of a coronary ostium, potentially interfering with subsequent selective coronary cannulation. In addition to commissural alignment, the geometry and orientation of the transcatheter valve frame relative to the coronary ostia may influence the feasibility of coronary re-access.
The Evolut FX Plus transcatheter heart valve incorporates three enlarged frame cells designed to facilitate coronary access. This modification is intended to increase the likelihood that at least one large cell is favorably positioned relative to each coronary ostium. However, prospective data evaluating selective coronary cannulation through these large cells and the relationship between large-cell orientation, commissural alignment, and coronary anatomy in clinical practice remain limited.
The study will enroll approximately 122 patients aged 65 years or older with severe aortic stenosis undergoing TAVI with the Evolut FX Plus valve. Immediately after valve implantation, selective cannulation of the left and right coronary arteries through the large-cell frame will be attempted using standard diagnostic coronary catheters. The primary endpoint is the successful selective coronary cannulation rate through the Evolut FX Plus large-cell frame, assessed separately for the left and right coronary arteries. Successful selective coronary cannulation is defined as stable engagement of a diagnostic catheter at the coronary ostium allowing coronary contrast injection.
Cardiac computed tomography (CT) performed 3 to 6 months after TAVI will provide a detailed assessment of the spatial relationship between the implanted transcatheter heart valve and the coronary ostia. CT-based assessments will include large cell-to-coronary alignment, alignment between the center of the transcatheter valve leaflet and the coronary ostium, and commissural alignment between the native and transcatheter aortic valves. Follow-up CT will also be used to evaluate findings of valve thrombosis, including leaflet, supravalvular, subvalvular, and sinus hypoattenuation.
Detailed description
TAVI will be performed according to standard clinical practice. A commissural alignment technique will be used during valve implantation, with appropriate orientation of the delivery system and fluoroscopic assessment during valve deployment.
Immediately after valve implantation, selective coronary cannulation of the left coronary artery and right coronary artery through the Evolut FX Plus large-cell frame will be attempted using standard diagnostic coronary catheters. The primary endpoint is the successful selective coronary cannulation rate through the large-cell frame, assessed separately for the left and right coronary arteries. Successful selective coronary cannulation is defined as stable engagement of the diagnostic catheter at the coronary ostium allowing coronary contrast injection.
Cardiac CT performed 3 to 6 months after TAVI will be analyzed to assess the spatial relationship between the implanted valve and the coronary ostia. CT-based assessments will include large cell-to-coronary alignment, alignment between the center of the transcatheter valve leaflet and the coronary ostium, commissural alignment between the native and transcatheter aortic valves, and findings of valve thrombosis, including leaflet, supravalvular, subvalvular, and sinus hypoattenuation.
Clinical efficacy and safety outcomes will be assessed at 30 days and 6 months. Clinical events will be defined according to Valve Academic Research Consortium-3 (VARC-3) criteria where applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing TAVI using Evolut FX Plus | – | –Patients aged 65 years or older with severe aortic stenosis who are scheduled to undergo TAVI with the Evolut FX Plus transcatheter heart valve and who meet all eligibility criteria. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.
Key inclusion criteria (3 listed)
- Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.
- Age ≥65 years.
- Ability and willingness to provide written informed consent for participation in the study.
Key exclusion criteria (8 listed)
- Inability to undergo contrast-enhanced cardiac CT before TAVI.
- Anomalous origin of a coronary artery.
- Bicuspid aortic valve.
- Previous surgical or transcatheter aortic valve replacement.
- Cardiogenic shock or hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Selective Coronary Cannulation Through the Evolut FX Plus Large-Cell Frame
Time frame: Day 0 (Immediately after Evolut FX Plus implantation)
The proportion of patients in whom successful selective coronary cannulation is achieved through the Evolut FX Plus large-cell frame, assessed separately for the left coronary artery and right coronary artery. Successful selective coronary cannulation is defined as stable engagement of a standard diagnostic catheter at the coronary ostium allowing coronary contrast injection.
6 secondary outcomes
Technical Success
Time frame: 30 days after TAVI
Devicel Success
Time frame: 30 days after TAVI
Clinical outcomes (Composite of All-Cause Mortality, All Stroke, or Procedure- or Valve-Related Hospitalization)
Time frame: 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Large Cell-to-Coronary Misalignment)
Time frame: 3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Leaflet Center-to-Coronary Misalignment)
Time frame: 3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Commissural Misalignment)
Time frame: 3 to 6 months after TAVI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis, run by Yonsei University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Guk Ko, Professor (+82-2-2228-8460, ygko@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Selective Coronary Cannulation Through the Evolut FX Plus Large-Cell Frame (time frame: Day 0 (Immediately after Evolut FX Plus implantation)). 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 10 Sep 2026.