Clinical Study of the inQB8 TTVR System

Description

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

Conditions

Tricuspid Valve Regurgitation

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Study Overview

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Study Details

Study overview

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

A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System

Clinical Study of the inQB8 TTVR System

Condition
Tricuspid Valve Regurgitation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Thousand Oaks

Los Robles Hosptial and Medical Center, Thousand Oaks, California, United States, 91360

Manhasset

North Shore University Hospital, Manhasset, New York, United States, 11030

Philadelphia

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States, 19104

Plano

Baylor Heart Hospital, Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

inQB8 Medical Technologies, LLC,

Study Record Dates

2029-10-31