None listed
Conditions
Brief 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.
Interventions
This is a pilot study on the safety and effectiveness of the 3PM ES360 introducer sheath. The 3PM ES360 is an expandable introducer sheath set, comprising of an expandable introducer sheath and compatible dilator. It is intended for use in transcatheter aortic valve replacement (TAVR) procedures. The procedure will be performed by experienced cardiologists on participants who are already scheduled to undergo a TAVR procedure. The procedure should take around one hour. This type of procedure requ
This is a pilot study on the safety and effectiveness of the 3PM ES360 introducer sheath. The 3PM ES360 is an expandable introducer sheath set, comprising of an expandable introducer sheath and compatible dilator. It is intended for use in transcatheter aortic valve replacement (TAVR) procedures. The procedure will be performed by experienced cardiologists on participants who are already scheduled to undergo a TAVR procedure. The procedure should take around one hour. This type of procedure requires a sheath so there would not be any added time for using this sheath, however the procedure may take an additional 10 minutes to collect study data. Participants will be followed up for 30 days post procedure at which point they will be exited from the study. The study will be monitored by an independent Contract Research Organisation (CRO) who will review all relevant medical notes. The sponsor and CRO will train the study team on the study and the device.
Sponsors
Three Peaks Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Indicated for TAVR procedure incorporating a compatible device
Exclusion criteria
1. Prior intervention/stenting in the aorta and/or ilio-femoral arteries 2. Severely calcified or highly tortuous peripheral vasculature 3. Medical, social, or psychological condition that in the opinion of an Investigator precludes the subject from appropriate consent 4. Concurrently participating in another cardiovascular device trial 5. Subject refuses a blood transfusion 6. Recent cerebrovascular accident or transient ischemic attack (within 90 days) 7. Recent emergency surgery for any reason (within 30 days) 8. Any percutaneous peripheral interventional procedure performed within 30 days prior to the procedure 9. Aged under 18 at time of consent
Outcome results
None listed