Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06611579

Clinical Study of the inQB8 TTVR System

Led by inQB8 Medical Technologies, LLC · Updated on 2025-11-04

50

Participants Needed

6

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Clinical Study of the inQB8 TTVR System

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

2

Los Robles Hosptial and Medical Center

Thousand Oaks, California, United States, 91360

Actively Recruiting

3

Piedmont Atlanta Hospital

Atlanta, Georgia, United States, 30309

Actively Recruiting

4

North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

5

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

6

Baylor Heart Hospital

Plano, Texas, United States, 75093

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Clinical Study of the inQB8 TTVR System | DecenTrialz