Search / Trial NCT06611579

Clinical Study of the InQB8 TTVR System

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

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

ClinConnect Summary

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 Inqb8 Medical Technologies, Llc

inqb8 medical technologies, LLC, is a pioneering clinical trial sponsor dedicated to advancing healthcare innovations through the development and commercialization of cutting-edge medical technologies. With a strong focus on improving patient outcomes, inqb8 collaborates with healthcare professionals and researchers to conduct rigorous clinical trials that evaluate the safety and efficacy of its novel products. Leveraging a team of experienced experts in regulatory affairs, clinical research, and product development, inqb8 is committed to delivering transformative solutions that address unmet medical needs and enhance the quality of care across diverse therapeutic areas.

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