CompletedNot Applicable

Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

United States258 participantsStarted 2023-11-15

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Rate of VARC-3 Major & Minor Vascular complications

Timeframe: within 30 days of TAVR procedure

Time to Hemostasis

Timeframe: During the procedure

Trial details

NCT IDNCT05936996

SponsorEssential Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-20

View on ClinicalTrials.gov More Femoral Arteriotomy Closure trials