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

inQB8 Medical Technologies, LLC50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tricuspid Valve Regurgitation

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve using a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Cedars-Sinai Medical Center

Los Angeles, California, United States

RECRUITING

Los Robles Hosptial and Medical Center

Thousand Oaks, California, United States

RECRUITING

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Absence of device or procedure related major adverse events

Time frame: 30 days

Change in TR grade from baseline

Time frame: 30 days

Secondary Outcomes

Device and procedure related complications

Rate of Device and procedure related complications

Time frame: 30 days and 12 months

NYHA functional classification

Change in NYHA functional class from baseline