Clinical trial NCT05936996: Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Official title: Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Femoral Arteriotomy Closure
Keywords: MANTA
Arterial Closure Device
Large Bore Closure Device
Lead sponsor: Essential Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vascular Solutions LLC
name: Teleflex Medical Inc
First posted: 2023-07-10
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.

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.

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.

Primary outcomes:
measure: Rate of VARC-3 Major & Minor Vascular complications
timeFrame: within 30 days of TAVR procedure
measure: Time to Hemostasis
timeFrame: During the procedure
Secondary outcomes:
measure: Additional interventions: Required at large bore access site to address complications
timeFrame: within 30 days following the procedure
measure: Technical Success:
timeFrame: During the procedure
measure: Ambulation Success:
timeFrame: During procedure admission
measure: Treatment Success:
timeFrame: within 30 days of TAVR procedure
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Health Medical Center-Jacksonville
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York City
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Round Rock
country: United States
facility: Baylor Scott & White - Round Rock
state: Texas
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References: