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Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Sponsor: Essential Medical, Inc.
Summary
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.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
258
Start Date
2023-11-15
Completion Date
2025-10-30
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
MANTA Vascular Closure Device
The MANTA® Vascular Closure Device consists of a 14F or 18F MANTA® Closure Device, a 14F or 18F Sheath with Introducer, and an 8F Depth Locator. 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.
Locations (10)
Baptist Health Medical Center-Jacksonville
Jacksonville, Florida, United States
Orlando Health, Inc
Orlando, Florida, United States
Henry Ford Health
Detroit, Michigan, United States
University at Buffalo
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Scott & White - Round Rock
Round Rock, Texas, United States
Montreal Heart Institute
Montreal, Quebec, Canada