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CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement (CHATEAU)

12. juli 2026 oppdatert av: Eunpyeong St. Mary's Hospital

Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry

This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025. The purpose of the study is to assess clinical outcomes and valve performance after TAVR in real-world practice, with a focus on procedural strategies, valve-related factors, and long-term outcomes. Patient clinical information, imaging findings, procedural data, echocardiographic results, and follow-up outcomes will be collected from existing medical records. No additional intervention, treatment, or study-specific visit will be performed.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The CHATEAU Registry is an international, multicenter, observational registry of patients undergoing transcatheter aortic valve replacement. This study will retrospectively analyze consecutive 4,000 patients treated with TAVR at participating centers from January 1, 2021 to December 31, 2025. Follow-up clinical outcomes will be assessed through December 31, 2027.

Eligible patients are adults who underwent TAVR for aortic valve disease. Data will be collected from existing medical records, including baseline demographics, comorbidities, laboratory findings, pre-procedural imaging data, procedural details, device information, post-procedural echocardiographic findings, discharge medications, and clinical follow-up outcomes.

The study aims to evaluate the association between patient-, anatomy-, device-, and procedure-related factors and subsequent clinical outcomes and valve performance. Outcomes of interest may include all-cause death, cardiovascular death, stroke, myocardial infarction, heart failure hospitalization, pacemaker implantation, valve hemodynamic deterioration, aortic valve reintervention, paravalvular regurgitation, and other TAVR-related clinical events.

Because this is a retrospective observational study, all treatment decisions were made according to routine clinical practice at each participating institution. The study does not involve randomization, assignment of treatment, additional procedures, or additional patient visits. All data will be handled in accordance with applicable institutional review board requirements and privacy regulations.

Studietype

Observasjonsmessig

Registrering (Antatt)

4000

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Sør -Korea
      • Seoul, Sør -Korea, 03312
        • Rekruttering
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Osung Kwon, MD, PhD

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of consecutive adult patients who underwent clinically indicated transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers in the CHATEAU Registry. Clinical, imaging, procedural, echocardiographic, and follow-up data are retrospectively collected from routine clinical practice to evaluate long-term clinical outcomes and prosthetic valve performance in a real-world international cohort.

Beskrivelse

Inclusion Criteria:

  • Adults (≥18 years of age).
  • Patients who underwent transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers.
  • TAVR performed between January 1, 2021 and December 31, 2025.
  • Availability of baseline procedural and follow-up clinical data in the institutional registry or medical records.

Exclusion Criteria:

  • Patients with insufficient clinical or procedural data for outcome assessment.

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
Intervensjon / Behandling
CHATEAU Registry Cohort
Consecutive adult patients with severe aortic valve disease who underwent transcatheter aortic valve replacement (TAVR) between January 1, 2021 and December 31, 2025 at participating centers in the CHATEAU Registry. Clinical, imaging, procedural, and follow-up data are collected retrospectively from routine clinical practice.
Fremgangsmåte: Transcatheter Aortic Valve Replacement
Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-Cause Mortality
Tidsramme: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.
From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding
Tidsramme: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
Outcome events will be assessed during follow-up using routinely collected clinical and imaging data. Clinical events will be defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, where applicable, and adjudicated according to each participating center's standard clinical practice.
From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)

Samarbeidspartnere og etterforskere

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

Sponsor

Eunpyeong St. Mary's Hospital

Samarbeidspartnere

Kokura Memorial Hospital
RCF@ICPS

Etterforskere

  • Hovedetterforsker: Osung Kwon, MD, PhD, The Catholic University of Korea Eunpyeong St. Mary's Hospital

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 (Faktiske)

1. januar 2021

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

12. juli 2026

Først innsendt som oppfylte QC-kriteriene

12. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHATEAU-REG-001

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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