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.
Femoral Arteriotomy Closure
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.
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
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Baptist Health Medical Center-Jacksonville, Jacksonville, Florida, United States, 32207
Orlando Health, Inc, Orlando, Florida, United States, 32806
Henry Ford Health, Detroit, Michigan, United States, 48202
University at Buffalo, Buffalo, New York, United States, 14203
North Shore University Hospital, Manhasset, New York, United States, 11030
Mount Sinai Hospital, New York, New York, United States, 10029
Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232
Baylor Scott & White - Round Rock, Round Rock, Texas, United States, 78665
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
21 Years to
ALL
No
Essential Medical, Inc.,
2025-03-31