Transcatheter Valve Replacement for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: inQB8 Medical Technologies, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.

Eligibility Criteria

This trial is for individuals with severe or greater tricuspid valve regurgitation, who are stable and have been treated for heart failure. They must be anatomically suitable for the MonarQ TTVR System. Those in other studies, needing urgent surgery, or with refractory heart failure requiring advanced intervention cannot join.

Inclusion Criteria

Anatomically suitable for the MonarQ TTVR System

I have severe symptoms from heart valve leakage.

My heart and blood pressure are stable.

+1 more

Exclusion Criteria

Currently participating in another investigational biologic, drug or device study

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

I do not need any urgent surgeries, including heart surgery in the next year or heart procedures in the next 3 months.

+1 more

Participant Groups

The study is testing the safety and performance of a new device called the inQB8 MonarQ Tricuspid Valve Replacement System through a procedure known as transcatheter tricuspid valve replacement at multiple centers.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System