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

May 14, 2026 updated by: inQB8 Medical Technologies, LLC

A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruges, Belgium, 8000
        • Recruiting
        • Az Sint-Jan Brugge Av
        • Principal Investigator:
          • Jan Van der Heyden
        • Contact:
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Neil Fam
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar
        • Contact:
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Hosptial and Medical Center
        • Principal Investigator:
          • Saibal Kar
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Atlanta Hospital
        • Principal Investigator:
          • Pradeep Yadav
        • Contact:
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Principal Investigator:
          • Bruce Rutkin
        • Contact:
        • Principal Investigator:
          • Elana Koss
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Heart Hospital
        • Principal Investigator:
          • Robert Smith
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Device: Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve using a transcatheter approach
Other Names:
  • inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence of device or procedure related major adverse events
Time Frame: 30 days
30 days
Change in TR grade from baseline
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and procedure related complications
Time Frame: 30 days and 12 months
Rate of Device and procedure related complications
30 days and 12 months
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
30 days, 6 months, 1 year, and through study completion, an average of 1 year
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
30 days, 6 months, 1 year, and through study completion, an average of 1 year
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
30 days, 6 months, 1 year, and through study completion, an average of 1 year
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
30 days, 6 months, 1 year, and through study completion, an average of 1 year
Hospitalization
Time Frame: 30 days, 6 months, 1 year, and through study completion, an average of 1 year
Rate of all-cause hospitalization
30 days, 6 months, 1 year, and through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

inQB8 Medical Technologies, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-21001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe