Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes (ACCESS MANTA)

Essential Medical

Status: Completed

Conditions: Femoral Arteriotomy Closure

Treatments: Device: MANTA Vascular Closure Device

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05936996

ST-3659

Details and patient eligibility

About

This is an observational study designed to evaluate the safety and clinical outcomes of the MANTA® Vascular Closure Device (VCD) (the MANTA® Device) in TAVR procedures. The study will enroll participants who are undergoing a TAVR procedure. The purpose of this study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Full description

In the U.S. and Canada, the MANTA® Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. In Israel, the 14F MANTA® is indicated for closure of femoral arterial access sites following the use of 10-14F devices or sheaths (maximum OD/profile of 18F), and the 18F MANTA® device is indicated for closure of femoral arterial access sites following the use of 15-18F devices or sheaths (maximum OD/profile of 25F). The purpose of the study is to examine and collect data on outcomes of contemporary MANTA® large bore closure in standard of care (SOC) TAVR procedures with on-label use of the MANTA® device including appropriate patient selection and proper vascular access.

Enrollment: 258 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate meets criteria for on-label use of MANTA® VCD as specified in the country-specific MANTA® VCD Instructions for Use (IFU), per judgement of the investigator.
• Age ≥21 years

Exclusion criteria

• Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.