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

Summary

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

Eligibility

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

Conditions2

Locations6 sites

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