NCT Number: NCT05936996
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.
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Notify Me21 year and older
All sexes
Observational
Montreal Heart Institute, Montreal, Quebec, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within 30 days of TAVR procedure
Time frame: During the procedure
The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
Time frame: within 30 days following the procedure
The percentage of subjects with additional interventions required at large bore access site to address bleeding or other large bore access site complications (e.g., bare or covered stent or surgical repair), within 30 days following the procedure
Time frame: During the procedure
The percentage of subjects in whom closure is obtained with the MANTA® VCD without the use of unplanned endovascular or surgical intervention
Time frame: During procedure admission
The percentage of a previously ambulatory subjects (until day of TAVI) who are able to ambulate for at least 20 feet/6 meters without re-bleeding.
Time frame: within 30 days of TAVR procedure
The percentage of subjects in whom the time to Hemostasis ≤10 minutes and have no Large Bore Access Related Major VARC-3 complications within 30 days.
Essential Medical, Inc.
Industry
Acronym: ACCESS MANTA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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