The multi-centre, prospective, single-arm MANTA Ultra Study has been designed to demonstrate the safety of the MANTA ultrasound-guided closure, which does not need to depend on pre-procedural depth locator measurements.
It will enrol up to 150 patients, who are already undergoing elective transcatheter aortic valve replacement (TAVR) procedures with planned percutaneous femoral arterial access, at up to 15 investigational sites across Canada and the US.
The study has a primary safety endpoint of any large bore access-site related Valve Academic Research Consortium-2 (VARC-2) Major Vascular Complication within 30 days.
Teleflex stated that the cause of access site complications is related to higher rates of morbidity and mortality, as well as the increased costs that are associated with prolonged length of stay.
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The use of ultrasound-guided access can result in a reduced risk of life-threatening, major and minor bleed complications, as well as lower the risk of major and minor vascular complications at the access site.
Additionally, the clinical trial aims to show that ultrasound enables accurate deployment and positive positioning of the MANTA Device anchor in the vessel with visualisation of the access site during its deployment.
If successful, this process will allow the device to be used in clinical scenarios when the baseline arterial depth is not measured or may have changed during or after the operation.
Teleflex stated that the MANTA Device ultrasound-guided closure is developed to be an alternative process to the standard pre-procedural depth locator measurement approach, providing surgeons with more procedural flexibility.
Teleflex medical director Chris Buller said: “The resourcing of the MANTA Ultra Study by Teleflex reflects our commitment to providing interventional cardiologists and surgeons with category-defining tools that enable difficult procedures and minimise complications – in this case, the complications attributable to large bore access that are inherent to transcatheter aortic valve implantation (TAVI) procedures.”
The study’s secondary endpoint is marked by any large bore access-site related VARC-2 minor vascular complication within 30 days.
The secondary effectiveness endpoints include time to hemostasis, treatment success, ambulation success, time to ambulation, procedure time and technical success.