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https://repository.monashhealth.org/monashhealthjspui/handle/1/56869| Title: | Safety and Effectiveness of an Expandable/Retractable Introducer Sheath. | Registration Date: | 12-May-2023 | Monash Health Site(s): | Victorian Heart Hospital Monash Medical Centre Jessie McPherson Private Hospital |
Trial Phase: | Not Applicable | Summary: | The purpose of this study is to establish preliminary clinical safety, effectiveness, and useability data for the ES360 expandable/retractable introducer sheath in transcatheter aortic valve replacement (TAVR) procedures. It is anticipated that the device will reduce major vascular injury and major bleeding events associated with transfemoral TAVR procedures. The device is also hypothesised to reduce the number of sheath insertions required during the procedure when used with TAVR delivery systems. | Type: | Clinical trial | Registry ID: | ACTRN12623000479606 | URL: | https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385452 |
| Appears in Collections: | Clinical Trials |
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