Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
- Conditions
- Femoral Arteriotomy Closure
- Registration Number
- NCT05936996
- Lead Sponsor
- Essential Medical, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Hemostasis During the procedure The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
Rate of VARC-3 Major & Minor Vascular complications within 30 days of TAVR procedure
- Secondary Outcome Measures
Name Time Method Ambulation Success: 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.
Treatment Success: 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.
Technical Success: 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
Additional interventions: Required at large bore access site to address complications 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
Trial Locations
- Locations (10)
Montefiore Medical Center
🇺🇸New York, New York, United States
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 City, 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
🇨🇦Montréal, Quebec, Canada