Clinical Study of the inQB8 TTVR System

Last updated: May 8, 2025
Sponsor: inQB8 Medical Technologies, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transcatheter Tricuspid Valve Replacement

Clinical Study ID

NCT06611579
CIP-21001
  • Ages > 18
  • All Genders

Study Summary

Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Anatomically suitable for the MonarQ TTVR System

  • Symptomatic, tricuspid regurgitation (TR) that is severe or greater

  • Adequately treated for heart failure based upon medical standards

  • Hemodynamically stable

Exclusion

Exclusion Criteria:

  • Need for emergent or urgent surgery for any reason, any planned cardiac surgerywithin the next 12 months (365 days), or any planned percutaneous cardiac procedurewithin the next 90 days

  • Refractory Heart Failure (HF) that requires or required advanced intervention

  • Any condition, in the opinion of the investigator, making it unlikely the patientwill be able to complete all protocol procedures and follow-up.

  • Currently participating in another investigational biologic, drug or device study

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Transcatheter Tricuspid Valve Replacement
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
October 31, 2029

Study Description

The study is a multi-center, prospective, single-arm study to assess safety and performance of the inQB8 Medical Technologies MonarQ Tricuspid Valve Replacement System.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Los Robles Hosptial and Medical Center

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Baylor Heart Hospital

    Plano, Texas 75093
    United States

    Site Not Available

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