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Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

NCT05936996 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 258

Last updated 2025-11-12

No results posted yet for this study

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

Interventions

DEVICE

MANTA Vascular Closure 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.

Sponsors & Collaborators

  • Vascular Solutions LLC

    collaborator INDUSTRY

  • Teleflex Medical Inc

    collaborator UNKNOWN

  • Essential Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-06-20
Completion
2025-10-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936996 on ClinicalTrials.gov