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Prueba del sistema de administración y filtro F2 para protección embólica durante TAVR (SHIELD)

4 de noviembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Australia
    • Queensland
      • Spring Hill, Queensland, Australia, 4000
        • Aún no reclutando
        • St Andrews War Memorial Hospital
        • Contacto:
        • Investigador principal:
          • Karl Poon, MD
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Reclutamiento
        • Monash Health Public
        • Investigador principal:
          • Robert Gooley, MD
        • Contacto:
  • Estados Unidos
    • Florida
      • Naples, Florida, Estados Unidos, 34102
        • Aún no reclutando
        • NCH Baker Hospital-Naples Heart Institute
        • Contacto:
          • Kathy Byrd
          • Número de teléfono: (239)624-8113
        • Investigador principal:
          • Robert Cubeddu
    • Indiana
      • Indianappolis, Indiana, Estados Unidos, 46260
        • Reclutamiento
        • St. Vincent Hospital
        • Investigador principal:
          • James Hermiller, MD
        • Contacto:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Hospital
        • Investigador principal:
          • Brian O'Neill, MD
        • Contacto:
          • Stephen Krafchak
          • Número de teléfono: 313-972-4018
          • Correo electrónico: skrafch1@hfhs.org
        • Contacto:
          • Sara Poggio, RN
          • Número de teléfono: 313-916-0119
          • Correo electrónico: spoggio1@hfhs.org
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
    • New York
      • New York, New York, Estados Unidos, 10032
        • Reclutamiento
        • Cumc/Nyph
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Torsten Vahl, MD
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Reclutamiento
        • Cleveland Clinic Foundation
        • Investigador principal:
          • Amar Krishnaswamy, MD
        • Contacto:
          • Emily Tylicki
          • Número de teléfono: 216-287-8237
          • Correo electrónico: TYLICKE@ccf.org
      • Columbus, Ohio, Estados Unidos, 43214
        • Aún no reclutando
        • Ohio Health Research Institute (aka Riverside Methodist Hospital)
        • Investigador principal:
          • Steven Yakubov, MD
        • Contacto:
        • Contacto:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Aún no reclutando
        • University of Virginia Medical Center
        • Contacto:
          • Linda Bailes Bryceland
          • Número de teléfono: 434-982-1058
          • Correo electrónico: LGS2M@uvahealth.org
        • Investigador principal:
          • John Saxon

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

Procedimiento: Transcatheter Aortic Valve Replacement (TAVR)

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

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

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ability of the F2 CPC to provide neuroprotection during a TF TAVR procedure
Periodo de tiempo: 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)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Combined Safety and Efficacy - VARC-2
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Discharge or Day 5-10, whichever comes first; Day 30
Discharge or Day 5-10, whichever comes first; Day 30
Bleeding
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 8-72 hours post-procedure

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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
NIHSS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 8-72 hours post-procedure

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

EnCompass Technologies, Inc.

Colaboradores

DP Clinical, Inc.
Avania Pty Ltd

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de septiembre de 2025

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2024

Publicado por primera vez (Actual)

15 de noviembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ET03

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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