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Prospective Clinical Registry Evaluating Contemporary MANTA Outcomes

Femoral Arteriotomy Closure

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    21 and up

Participation 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.

Study Location

Montreal Heart Institute
Montreal Heart Institute
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Natasha Moisan

Study Sponsored By
Essential Medical, Inc.
Participants Required
More Information
Study ID: NCT05936996