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Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry

7. september 2026 oppdatert av: Yonsei University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

122

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Young-Guk Ko, Professor
  • Telefonnummer: +82-2-2228-8460
  • E-post: ygko@yuhs.ac

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.

Beskrivelse

Inclusion Criteria:

  1. Patients with severe aortic stenosis undergoing TAVI with the Evolut FX Plus transcatheter heart valve.
  2. Age ≥65 years.
  3. Ability and willingness to provide written informed consent for participation in the study.

Exclusion Criteria:

  1. Inability to undergo contrast-enhanced cardiac CT before TAVI.
  2. Anomalous origin of a coronary artery.
  3. Bicuspid aortic valve.
  4. Previous surgical or transcatheter aortic valve replacement.
  5. Cardiogenic shock or hemodynamic instability.
  6. Chronic kidney disease stage 3b, 4, or 5, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m².
  7. Thrombocytopenia (platelet count <100,000/μL) or an increased bleeding risk precluding antiplatelet or anticoagulant therapy.
  8. Allergy or hypersensitivity to aspirin or clopidogrel precluding antiplatelet therapy in patients without an indication for oral anticoagulation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Successful Selective Coronary Cannulation Through the Evolut FX Plus Large-Cell Frame
Tidsramme: 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.
Day 0 (Immediately after Evolut FX Plus implantation)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Technical Success
Tidsramme: 30 days after TAVI
Technical success following TAVI with the Evolut FX Plus valve, assessed according to the study protocol and applicable VARC-3 criteria.
30 days after TAVI
Devicel Success
Tidsramme: 30 days after TAVI
Device success following TAVI with the Evolut FX Plus valve, assessed according to the study protocol and applicable VARC-3 criteria.
30 days after TAVI
Clinical outcomes (Composite of All-Cause Mortality, All Stroke, or Procedure- or Valve-Related Hospitalization)
Tidsramme: 6 months after TAVI
Composite of All-Cause Mortality, All Stroke, or Procedure- or Valve-Related Hospitalization
6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Large Cell-to-Coronary Misalignment)
Tidsramme: 3 to 6 months after TAVI
1) 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.
3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Leaflet Center-to-Coronary Misalignment)
Tidsramme: 3 to 6 months after TAVI

  1. 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.

  2. Moderate or Greater Commissural Misalignment
3 to 6 months after TAVI
CT-based Secondary Outcome (Moderate or Greater Commissural Misalignment)
Tidsramme: 3 to 6 months after TAVI

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.
3 to 6 months after TAVI

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yonsei University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

29. september 2026

Primær fullføring (Antatt)

30. september 2028

Studiet fullført (Antatt)

31. mars 2029

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

7. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1-2026-0038

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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