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Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial

12. juni 2026 oppdatert av: Resonova (Shanghai) Medtech Limited

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Resonova® CHORDS® Cerebral Protection System in Capturing and Removing Embolic Debris During Transcatheter Aortic Valve Replacement

This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during Transcatheter Aortic Valve Replacement (TAVR). A total of 240 eligible participants will be enrolled and randomized in a 1:1 ratio to undergo TAVR either with the CHORDS® Cerebral Protection System (Test group) or the Sentinel System (Control group).All the participants will be followed up at 30 days and 90 days post-procedure.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina
        • Rekruttering
        • Zhongshan Hospital, Fudan University
        • Hovedetterforsker:
          • Junbo Ge, MD
        • Ta kontakt med:
        • Underetterforsker:
          • Wenzhi Pan, MD
    • Anhui
      • Bengbu, Anhui, Kina
        • Rekruttering
        • The First Affiliated Hospital of Bengbu Medical College
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jinjun Liu
      • Hefei, Anhui, Kina
        • Rekruttering
        • Anhui Provincial Hospital
        • Hovedetterforsker:
          • Fan Ouyang
        • Ta kontakt med:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • Beijing Anzhen Hospital, Capital Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Xinmin Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina
        • Rekruttering
        • The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
        • Hovedetterforsker:
          • Zhihui Zhang
        • Ta kontakt med:
    • Fujian
      • Fuzhou, Fujian, Kina
        • Rekruttering
        • Fujian Medical University Union Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lianglong Chen
      • Fuzhou, Fujian, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital Of Fujian Medical University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dajun Chai
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Guangdong Provincial People's Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jianfang Luo
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • The First Affiliated Hospital of Sun Yat-sen University
        • Hovedetterforsker:
          • Yi Li
        • Ta kontakt med:
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Southern Medical University Nanfang Hospital
        • Hovedetterforsker:
          • Jiancheng Xiu
        • Ta kontakt med:
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yangxin Chen
        • Hovedetterforsker:
          • Haifeng Zhang
    • Jiangxi
      • Nanchang, Jiangxi, Kina
        • Rekruttering
        • The First Affiliated Hospital of Nanchang University
        • Hovedetterforsker:
          • Xiaoping Peng
        • Ta kontakt med:
    • Shandong
      • Qingdao, Shandong, Kina
        • Rekruttering
        • Qingdao University Affiliated Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zhexun Lian
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Rekruttering
        • West China Hospital, Sichuan University
        • Hovedetterforsker:
          • Jun Shi
        • Ta kontakt med:
    • Zhejiang
      • Wenzhou, Zhejiang, Kina
        • Rekruttering
        • The First Affiliated Hospital of Wenzhou Medical University
        • Hovedetterforsker:
          • Hao Zhou
        • Ta kontakt med:

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

Beskrivelse

Inclusion Criteria:

  • Male or non-pregnant female, ≥18 years
  • Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system.
  • Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters without significant stenosis (> 70%)
  • Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up.

Exclusion Criteria:

General

  • Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure.
  • Acute myocardial infarction ≤ 30 days before the intended treatment
  • Pure aortic regurgitation
  • Pre-existing prosthetic aortic valve
  • Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
  • Contraindication to antiplatelet and/or anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions
  • Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic
  • Vasculature (ie, right radial/brachial artery, carotid artery) precluding the device access
  • Patients whose brachiocephalic or left carotid artery reveals significant stenosis（>70%）, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TAVR+CHORDS
Participants undergo TAVR with the CHORDS® Cerebral Protection System
Enhet: CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Aktiv komparator: TAVR+Sentinel
Participants undergo TAVR with the Sentinel Cerebral Protection System
Enhet: Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Tidsramme: 30 days post-procedure
MACCE: all-cause death, disabling and non-disabling stroke, and Acute Kidney Injury (AKI) Stage 3 or higher at discharge or within7 days post-procedure, whichever occurs first (definitions of all-cause death, stroke, and AKI are based on VARC-3 criteria)
30 days post-procedure
Total new lesion volume (TLV, mm³) in protected territories(DW-MRI)
Tidsramme: 2-7 days post-procedure
TLV will be assessed by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI). Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery
2-7 days post-procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The perentage of patient with device success
Tidsramme: Acute post-procedure
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
Acute post-procedure
The percentage of patient with procedural success
Tidsramme: Acute post-procedure
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
Acute post-procedure
Total new lesion volume in the the protected territories and all territories(DW-MRI)
Tidsramme: 2-7 days post-procedure
Assessed by DW-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
2-7 days post-procedure
Total new lesion volume in the protected territories and all territories(FLAIR-MRI)
Tidsramme: 30 days post-procedure
Assessed by FLAIR-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
30 days post-procedure
Change in mRS from baseline
Tidsramme: Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by modified Rankin score
Discharge (up to 7 days post-procedure), 30 days post-procedure
Change in NIHSS from baseline
Tidsramme: Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by NIH Stroke Scale
Discharge (up to 7 days post-procedure), 30 days post-procedure
Incidence of MACCE
Tidsramme: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
MACCE includes:all-cause mortality, disabling and non-disabling stroke, Acute kidney injury(Stage 3 or higher). Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Incidence of major vascular complications
Tidsramme: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Histopathological analysis of captured thrombus/debris
Tidsramme: Acute post-procedure
Histopathological analysis includes type, size and number
Acute post-procedure

Samarbeidspartnere og etterforskere

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

Sponsor

Resonova (Shanghai) Medtech Limited

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)

31. oktober 2025

Primær fullføring (Antatt)

30. september 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

6. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHORDS-2025

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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