Teleflex has announced the first patient enrolment in a clinical registry that is intended to examine and collect data on outcomes of contemporary on-label use of the Manta vascular closure device (VCD) in standard of care transcatheter aortic valve implantation (TAVI) procedures. The registry will include appropriate patient selection and proper vascular access.
Enrolling at least 250 patients in up to 15 major TAVI institutions across the USA and Canada, the ACCESS-MANTA registry is an international, multicentre, prospective, observational, single-arm clinical registry. It will employ the primary objectives of safety, defined by VCD large bore access site-related Valve Academic Research Consortium-3 (VARC-3) major and minor vascular complications within 30 days of the TAVI procedure, and effectiveness, defined by time to haemostasis or the elapsed time between Manta device deployment and the first observed and confirmed arterial haemostasis. The study will also evaluate technical success, treatment success, ambulation success, discharge readiness, and procedure time.
“Large bore access site complications are recognised as morbid, driving increased costs and prolonged length-of-stay,” said Teleflex Interventional medical director, Christopher Buller. “That is why percutaneous cardiac and peripheral procedures, such as TAVI, that are performed through large bore arteriotomies, need dedicated closure technology that is safe and effective as well as procedurally efficient.”
“The Manta device demonstrated those attributes in the pivotal SAFE MANTA IDE clinical trial,” Buller added. “However, TAVI practice has since evolved to embrace routine access site imaging, awake procedures, somewhat smaller delivery systems and sheaths, lower-risk patients, and considerably higher per-operator experience. The ACCESS-MANTA registry will allow us to understand the degree to which these changes, coupled with a dedicated device that is optimally deployed, may improve large bore outcomes.”
The study chair is George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA). The principal investigators of the study include Sahil Khera (Mount Sinai Hospital, New York, USA) and Danny Dvir (Shaare Zedek Hospital Center, Jersualem, Israel).
“We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA Registry,” said Khera, co-global principal investigator. “The study focuses on on-label use of the Manta device, appropriate patient selection using pre-TAVI computed tomography (CT) imaging, and proper vascular access, all of which reflect the standard practice at our world class, high-volume TAVI centre. We look forward to this contribution to the advancement of large bore access and closure.”