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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 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

122

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Young-Guk Ko, Professor
  • Numer telefonu: +82-2-2228-8460
  • E-mail: ygko@yuhs.ac

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Successful Selective Coronary Cannulation Through the Evolut FX Plus Large-Cell Frame
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Technical Success
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Yonsei University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

29 września 2026

Zakończenie podstawowe (Szacowany)

30 września 2028

Ukończenie studiów (Szacowany)

31 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

31 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2026

Pierwszy wysłany (Rzeczywisty)

10 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 1-2026-0038

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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