The ShortCut Post-Market Study (ShortCut PMS)
A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
- To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
- To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male or female ≥ 22 years of age.
- Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
- Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
- Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
Exclusion Criteria:
- Any contraindication as specified in the approved device label.
- An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
- Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
- Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability.
- Left ventricle ejection fraction < 30%.
- Ongoing severe infection, sepsis or endocarditis.
- Patient has renal insufficiency (GFR < 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
- Need for emergency surgery for any reason.
- Life expectancy is less than 1 year.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Safety Assessment
Periodo de tiempo: At discharge or 7 days post-procedure, whichever occurs first
|
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC):
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At discharge or 7 days post-procedure, whichever occurs first
|
|
Primary Effectiveness Assessment
Periodo de tiempo: Immediately after TAVR procedure
|
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
|
Immediately after TAVR procedure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- CLN-0003581
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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