Clinical Study of the inQB8 TTVR System
Launched by INQB8 MEDICAL TECHNOLOGIES, LLC · Sep 20, 2024
Trial Information
Current as of July 31, 2025
Recruiting
Keywords
ClinConnect Summary
The Clinical Study of the InQB8 TTVR System is looking at a new device called the MonarQ Tricuspid Valve Replacement System. This study aims to find out how safe and effective this device is for people with a condition known as tricuspid valve regurgitation (TR), where the heart's tricuspid valve doesn't close properly and can lead to various symptoms. This trial is not yet recruiting participants, but it will involve people between the ages of 65 and 74 and is open to all genders.
To be eligible for this study, participants must have severe TR and must have already received appropriate treatment for their heart failure. They should also be stable, meaning their condition isn't worsening. However, individuals who require urgent surgery, have advanced heart failure needing more intensive treatment, or are involved in other clinical studies cannot take part. If someone joins the study, they can expect to undergo assessments related to the new device and will need to follow up on their health throughout the trial. This trial could potentially help improve treatment options for severe TR in the future.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Manhasset, New York, United States
Philadelphia, Pennsylvania, United States
Plano, Texas, United States
Thousand Oaks, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported