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NCT Number: NCT06611579

Clinical Study of the inQB8 TTVR System (The MonarQ Study)

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

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint-Jan Brugge AV, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within 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 patient will be able to complete all protocol procedures and follow-up.
  • Currently participating in another investigational biologic, drug or device study

Treatment and study plan

Transcatheter Tricuspid Valve Replacement

Device

Replacement of the tricuspid valve using a transcatheter approach

Other names: inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Primary outcomes

  1. Absence of device or procedure related major adverse events

    Time frame: 30 days

  2. Change in TR grade from baseline

    Time frame: 30 days

Secondary outcomes

  1. Device and procedure related complications

    Time frame: 30 days and 12 months

    Rate of Device and procedure related complications

  2. NYHA functional classification

    Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year

    Change in NYHA functional class from baseline

  3. Six-minute-walk test

    Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year

    Change in distance from baseline

  4. Health status - KCCQ

    Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year

    Change in quality of life from baseline

  5. TR grade

    Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year

    Change in TR Grade from baseline

  6. Hospitalization

    Time frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year

    Rate of all-cause hospitalization

Sponsors and collaborators

Lead sponsor

inQB8 Medical Technologies, LLC

Industry

Registry information

Official study title

A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Sep 25, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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