inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System in Severe or Greater Tricuspid Regurgitation

What is the Purpose of this Study?

This study focuses on people who were diagnosed with symptomatic severe tricuspid valve leakage. The purpose of this study is to learn whether an experimental device called the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement (TTVR) System (or MonarQ TTVR System) is safe and efficient to treat a leaky tricuspid valve. The tricuspid valve is 1 of 4 valves in the heart. When this valve is not working properly, it does not close tightly enough and can cause a leak; therefore, the blood will flow in both directions, causing less blood to flow into the lungs. The MonarQ device is a valve system that is designed to be implanted into the patient’s heart to replace the diseased native valve and eventually reduce or stop leaking of the valve. This study is an early feasibility study, meaning the experimental device will be used in a small number of patients.


Eligibility

  • * 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
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Clinical Study of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Study Details
Disease Type/Condition

Tricuspid valve regurgitation

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

STUDY00004045

ClinicalTrials.gov ID

NCT06611579

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Tricuspid valve regurgitation

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

III

IRB Number

21001-US

ClinicalTrials.gov ID

NCT06611579

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org