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Teste do filtro F2 e sistema de entrega para proteção embólica durante TAVR (SHIELD)

4 de novembro de 2026 atualizado por: EnCompass Technologies, Inc.

A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection Catheter Vs. Unprotected Transfemoral Transcatheter Aortic Valve Replacement

The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially available devices.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The study is designed to demonstrate that the F2 CPC performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection Catheter (CPC) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).

Tipo de estudo

Intervencional

Inscrição (Estimado)

500

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Austrália
    • Queensland
      • Spring Hill, Queensland, Austrália, 4000
    • Victoria
      • Clayton, Victoria, Austrália, 3168
  • Estados Unidos
    • Florida
      • Naples, Florida, Estados Unidos, 34102
        • Ainda não está recrutando
        • NCH Baker Hospital-Naples Heart Institute
        • Contato:
          • Kathy Byrd
          • Número de telefone: (239)624-8113
        • Investigador principal:
          • Robert Cubeddu
    • Indiana
      • Indianappolis, Indiana, Estados Unidos, 46260
        • Recrutamento
        • St. Vincent Hospital
        • Investigador principal:
          • James Hermiller, MD
        • Contato:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Hospital
        • Investigador principal:
          • Brian O'Neill, MD
        • Contato:
        • Contato:
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
    • New York
      • New York, New York, Estados Unidos, 10032
        • Recrutamento
        • Cumc/Nyph
        • Contato:
        • Contato:
        • Investigador principal:
          • Torsten Vahl, MD
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Recrutamento
        • Cleveland Clinic Foundation
        • Investigador principal:
          • Amar Krishnaswamy, MD
        • Contato:
      • Columbus, Ohio, Estados Unidos, 43214
        • Ainda não está recrutando
        • Ohio Health Research Institute (aka Riverside Methodist Hospital)
        • Investigador principal:
          • Steven Yakubov, MD
        • Contato:
        • Contato:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Ainda não está recrutando
        • University of Virginia Medical Center
        • Contato:
        • Investigador principal:
          • John Saxon

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Key Inclusion Criteria:

  1. Age ≥ 21 and ≤ 90 years
  2. Patient meets the established criteria and indications for commercially available TAVR (e.g., balloon expandable SAPIEN valve platform, self-expanding CoreValve platform, or Navitor TAVI System) via transfemoral access and is scheduled to undergo TAVR per their treating physician.
  3. Patient is willing and able to comply with protocol-specified follow-up evaluations.
  4. Patient is able and willing to provide written informed consent

Key Exclusion Criteria:

General Exclusion Criteria:

Participants are not eligible for the study if any of the following criteria are present:

General Exclusion Criteria:

  1. Requires an urgent or emergent TAVR procedure.
  2. Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure (e.g., pacemaker placement, BAV, PCI) or planned within 30 days post-TAVR procedure.
  3. Current or planned participation in any investigational device/biopharma study during the duration of this study protocol.
  4. Diagnostic cardiac catheterization within 10 days prior to TAVR procedure (Note: unplanned diagnostic catheterization is allowed during TAVR procedure, but must be performed prior to insertion of the investigational device into the vasculature).
  5. Concomitant non-valvular intervention, vascular intervention, or leaflet modification is planned at time of TAVR procedure. (Note: balloon aortic valvuloplasty during TAVR procedure is permitted).
  6. Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
  7. Prior prosthetic heart valve in any position.
  8. Known intracardiac thrombus.
  9. Active infection or endocarditis.
  10. Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, nickel-titanium and/or contrast sensitivity that cannot be adequately pre-medicated.
  11. Presence or history of bleeding diathesis or coagulopathy.
  12. Contraindicated for anti-platelet and/or anticoagulant therapy.
  13. Refuses blood transfusion.
  14. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the 3 months prior to TAVR procedure.
  15. Renal insufficiency (creatinine > 2.5 mg/dL or GFR < 30) and/or renal replacement therapy at the time of screening.
  16. Hepatic failure (Child-Pugh class C).
  17. Presenting with cardiogenic shock or requiring vasopressor or inotropic support, or with severe hypotension (systolic blood pressure < 90 mm Hg) at the time of randomization.
  18. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30%.
  19. Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Female participants of child-bearing potential must have a negative pregnancy test at screening.
  20. Any other condition that in the opinion of the investigator precludes study participation or poses a significant hazard to the patient.

Neurological Exclusion Criteria:

  1. Modified Rankin Scale (mRS) ≥ 2 at screening.
  2. Cerebrovascular event including TIA within 6 months of the procedure.
  3. Active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
  4. Severe visual, auditory, or learning impairment.
  5. Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Note: use of general anesthesia during TAVR may affect neurocognitive function shortly after the procedure. While not an exclusion criterion, it is recommended that general anesthesia not be used, if possible.

Magnetic Resonance Imaging Exclusion Criteria:

  1. Body Mass Index (BMI) precluding imaging in scanner.
  2. Contraindications to MRI (participants with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
  3. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., patients with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
  4. Claustrophobia precluding MRI scanning.

Anatomical and CT Exclusion Criteria:

  1. Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
  2. Presence of cardiovascular implant in aorta and/or peripheral access vessels (e.g., thoracic endovascular aortic repair [TEVAR]/endovascular abdominal aortic aneurysm repair [EVAR], iliac/superficial femoral artery [SFA] stent).
  3. Access vessels with excessive tortuosity or complex anatomy that would likely necessitate a surgical cutdown approach (e.g., distance from skin to vessel is extensive).
  4. Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.
  5. Ascending aortic diameter less than 18 mm or greater than 38 mm measured 6 to 8 cm from the annulus.
  6. Transverse aortic arch diameter less than 18 mm or greater than 27 mm when measured immediately proximal to the ostium of the left subclavian artery.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: F2 Filter and Delivery System

The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure.
Dispositivo: F2 Filter and Delivery System

Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure

Procedimento: Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device
Comparador Ativo: No embolic protection device

No embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure.
Procedimento: Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ability of the F2 CPC to provide neuroprotection during a TF TAVR procedure
Prazo: 8 to 72 hours post procedure

Determined by pair-wise comparisons among participants in the eITT population (Finkelstein-Schoenfeld [FS] method) according to the following prespecified hierarchy of adverse outcomes:

  • Ischemic stroke (disabling or non-disabling); evaluated through 72 hours post-procedure
  • Total new lesion volume by DW-MRI; evaluated at 8-72 hours post-procedure by an independent MRI Core Laboratory.
8 to 72 hours post procedure
Major Adverse Events (MAE)
Prazo: 30 days post procedure

Defined as the composite of the following components at 30 days:

  • All-cause mortality
  • All stroke (disabling and non-disabling)
  • Acute kidney injury (Stage 3)
30 days post procedure

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Combined Safety and Efficacy - VARC-2
Prazo: Discharge or Day 5-10, whichever comes first

All-cause mortality; all stroke (disabling and non-disabling) and transient ischemic attack (TIA); acute kidney injury (stage 2 or 3, including renal replacement therapy)
Discharge or Day 5-10, whichever comes first
Neurological events (VARC-2 and NeuroARC)
Prazo: Discharge or Day 5-10, whichever comes first; Day 30

Stroke (subclassified as ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling); TIA
Discharge or Day 5-10, whichever comes first; Day 30
Incidence of acute kidney injury (AKIN)
Prazo: Discharge or Day 5-10, whichever comes first; Day 30

Subclassified as stage 1, 2, or 3 Acute Kidney Injury (VARC-2)
Discharge or Day 5-10, whichever comes first; Day 30
Incidence of major vascular complications (VARC-3)
Prazo: Discharge or Day 5-10, whichever comes first; Day 30
Discharge or Day 5-10, whichever comes first; Day 30
Bleeding
Prazo: Discharge or Day 5-10, whichever comes first; Day 30

Incidence of life-threatening or disabling bleeding and major bleeding (VARC-2) - life-threatening or disabling bleeding; major bleeding
Discharge or Day 5-10, whichever comes first; Day 30
Major adverse embolic events (MAEE)
Prazo: Discharge or Day 5-10

Incidence of the composite of all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), and systemic embolization
Discharge or Day 5-10
Total volume of new lesions by DW-MRI
Prazo: 8-72 hours post-procedure

Assessed by an independent MRI Core Laboratory
8-72 hours post-procedure

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
NIHSS
Prazo: Discharge or Day 5-10, whichever comes first; Day 30

NIHSS worsening (increase of 2 or more from baseline)
Discharge or Day 5-10, whichever comes first; Day 30
MoCA
Prazo: Discharge or Day 5-10, whichever comes first; Day 30

MoCA worsening (decrease of 2 or more from baseline)
Discharge or Day 5-10, whichever comes first; Day 30
Number of new lesions by DW-MRI
Prazo: 8-72 hours post-procedure

Assessed by an independent MRI Core Laboratory
8-72 hours post-procedure
Average size of new lesions by DW-MRI
Prazo: 8-72 hours post-procedure

Assessed by an independent MRI Core Laboratory
8-72 hours post-procedure
Largest per-subject single new lesion by DW-MRI
Prazo: 8-72 hours post-procedure

Assessed by an independent MRI Core Laboratory
8-72 hours post-procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

EnCompass Technologies, Inc.

Colaboradores

DP Clinical, Inc.
Avania Pty Ltd

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de setembro de 2025

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de novembro de 2024

Primeira postagem (Real)

15 de novembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2025

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ET03

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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