Search / Trial NCT06611579

Clinical Study of the InQB8 TTVR System

Launched by INQB8 MEDICAL TECHNOLOGIES, LLC · Sep 20, 2024

Trial Information

Current as of October 03, 2024

Not yet recruiting

Keywords

Description

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.

Gender

ALL

Eligibility criteria

  • 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Manhasset, New York, United States

Philadelphia, Pennsylvania, United States

Plano, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0