Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Completed

Conditions studied: Femoral Arteriotomy Closure

In brief

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.

Key facts

Study ID

NCT05936996

Run by

Essential Medical, Inc.

People needed

258

Starts

2023-11-15

Expected to finish

2025-10-30

Last updated by the study team

2025-11-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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, New York, United States
• Montefiore Medical Center — New York, 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 — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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