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.
Brief Title
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
610-331-7299
Central Contact Email
darra.bigelow@teleflex.com
Central Contact Role
Contact
Central Contact Phone
757-234-5819
Central Contact Email
katherine.thomas@teleflex.com
Completion Date
Completion Date Type
Estimated
Conditions
Femoral Arteriotomy Closure
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
MANTA
Arterial Closure Device
Large Bore Closure Device
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT05936996
Org Class
Industry
Org Full Name
Essential Medical, Inc.
Org Study Id
ST-3659
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Primary Outcomes
Outcome Measure
Rate of VARC-3 Major & Minor Vascular complications
Outcome Time Frame
within 30 days of TAVR procedure
Outcome Description
The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis
Outcome Measure
Time to Hemostasis
Outcome Time Frame
During the procedure
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
within 30 days following the procedure
Outcome Measure
Additional interventions: Required at large bore access site to address complications
Outcome Description
The percentage of subjects in whom closure is obtained with the MANTA® VCD without the use of unplanned endovascular or surgical intervention
Outcome Time Frame
During the procedure
Outcome Measure
Technical Success:
Outcome Description
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.
Outcome Time Frame
During procedure admission
Outcome Measure
Ambulation Success:
Outcome Description
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.
Outcome Time Frame
within 30 days of TAVR procedure
Outcome Measure
Treatment Success:
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Manaf Assafin
Investigator Email
massafin@montefiore.org