Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

NCT05936996 | Completed FDA Device

• 1 other identifier: ST-3659
• Study Type: observational
• Target: 258
• Locations: 2 countries
• Sites: 10

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.

Conditions

Femoral Arteriotomy Closure

Keywords

MANTA; Arterial Closure Device; Large Bore Closure Device

Outcome Measures

Primary Outcomes (2)

• Rate of VARC-3 Major & Minor Vascular complications

  within 30 days of TAVR procedure

• Time to Hemostasis

  The elapsed time between MANTA® deployment and first observed and confirmed arterial hemostasis

  During the procedure

Secondary Outcomes (4)

• Additional interventions: Required at large bore access site to address complications

  within 30 days following the procedure

• Technical Success:

  During the procedure

• Ambulation Success:

  During procedure admission

• Treatment Success:

  within 30 days of TAVR procedure

Interventions

MANTA Vascular Closure Device DEVICE

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Qualifying subjects undergoing TAVR using the MANTA® VCD for large bore closure.

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to give informed consent or unwilling to complete follow-up assessments.

Sponsors & Collaborators

• Essential Medical, Inc.: lead
• Vascular Solutions LLC: collaborator
• Teleflex Medical Inc: collaborator

Study Sites (10)

Baptist Health Medical Center-Jacksonville

Jacksonville, Florida, 32207, United States

Location

Orlando Health, Inc

Orlando, Florida, 32806, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Scott & White - Round Rock

Round Rock, Texas, 78665, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 10, 2023
• Study Start: November 15, 2023
• Primary Completion: June 20, 2025
• Study Completion: October 30, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (9)