Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures (4D-ICE)
Assessment of Utility of Siemens Healthineers 4D ICE and Premium CV System Workflow in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Procedures
The purpose of this study is to evaluate the imaging performance and procedural safety of a prototype 4D ICE catheter during real-time intracardiac imaging and to optimize device imaging parameters, compared with current standard imaging modalities.
TEE is the current standard of care and will serve as the primary imaging modality for clinical guidance during the EP and Structural Heart Disease (SHD) procedures. In this research protocol, TEE is not being investigated. ICE will be used as an adjunct imaging modality for research data collection and workflow evaluation only. All procedures will be performed using commercially available, FDA-approved Watchman devices, and no investigational implantable devices will be used. The use of ICE in this study does not modify the approved therapeutic device indication, implantation technique, or standard clinical decision-making.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a prospective clinical feasibility study designed to evaluate the imaging performance, workflow efficiency, and safety of a prototype 4D intracardiac echocardiography (ICE) catheter (ACUNAV Luxera) used in conjunction with the Siemens Premium CV ultrasound system during cardiac interventional procedures.
The ACUNAV Luxera 4D ICE system will be used adjunctively while standard-of-care transesophageal echocardiography (TEE) serves as the primary imaging modality. The study aims to determine whether 4D ICE provides comparable image quality and measurement accuracy to TEE, while maintaining procedural safety and enabling optimization of intracardiac imaging workflows.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Walid Saliba, MD
- Número de teléfono: 216-444-6810
- Correo electrónico: salibaw@ccf.org
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Reclutamiento
- Cleveland Clinical Foundation
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Sub-Investigador:
- Oussama Wazni, MD
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Contacto:
- Walid Saliba, MD
- Número de teléfono: 216-444-6810
- Correo electrónico: salibaw@ccf.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Be aged above 18 for adult participants
- Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
- Be able and willing to give informed consent
- (For concomitant cases only) Ablation will occur prior to LAAO implantation
Exclusion Criteria:
Potential subjects must not include:
- Subjects who are currently enrolled in any other investigational clinical studies
- Subjects with any bleeding diathesis
- Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- Subjects with known intracardiac thrombus
- Subjects with myocardial infarction within the prior two months
- Subjects with class IV angina or heart failure
- Subjects with sepsis or active infection
- Subjects with immune-deficiency or immune-compromised status
- Subjects with cerebral ischemic event in the prior six months
- Subjects with deep vein thrombosis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 4D ICE Adjunct Imaging
Participants undergoing left atrial appendage occlusion (LAAO) procedures (with or without concomitant electrophysiology procedures) will receive adjunctive imaging using the 4D ICE catheter while TEE remains the primary imaging modality for procedural guidance.
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Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of 4D ICE Imaging Performance
Periodo de tiempo: During the Procedure
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A composite score evaluating the overall technical and clinical adequacy of the 4D Intracardiac Echocardiography (ICE) catheter compared to standard-of-care imaging. The composite score is derived from three individual component assessments: Image Quality: Clarity, resolution, and artifact presence. Anatomical Visualization: Ability to clearly identify target cardiac structures. Procedural Guidance: Effectiveness of real-time images in guiding the procedure. Each component is graded by independent reviewers on a 5-point Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent). The final composite score is calculated as the sum of the three component scores, ranging from a minimum of 3 (worst performance) to a maximum of 15 (best performance). |
During the Procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Image Quality Assessment
Periodo de tiempo: During the Procedure
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Evaluation of 2D, 4D, and Doppler imaging quality using Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent).
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During the Procedure
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Workflow Efficiency
Periodo de tiempo: During the Procedure
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Procedural workflow metrics including imaging setup and acquisition time
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During the Procedure
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Measurement Acccuacy
Periodo de tiempo: During the Procedure
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Quantitative comparison of ICE-derived measurements (e.g., LAA sizing) with reference imaging (TEE or CT)
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During the Procedure
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Safety Outcomes
Periodo de tiempo: Up to 45 ± 15 days follow-up
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Incidence of device- or procedure-related adverse events
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Up to 45 ± 15 days follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Walid Saliba, MD, The Cleveland Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-552
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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