Assessment of the inQB8 Tricuspid Valve Replacement System
A Clinical Study of the inQB8 Transcatheter Tricuspid Valve Replacement System
This study is testing a new valve replacement system to see if it can safely help people with severe tricuspid valve problems feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | inQB8 Medical Technologies, LLC Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT06611579 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System in patients with severe tricuspid valve regurgitation. It is a multi-center, prospective, single-arm study that aims to gather data on the effectiveness of this transcatheter intervention. Participants will be monitored for their hemodynamic stability and overall health outcomes following the procedure. The study seeks to provide insights into a new treatment option for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are patients with symptomatic, severe tricuspid regurgitation who are anatomically suitable for the MonarQ TTVR System.
Not a fit: Patients requiring urgent surgery or those with refractory heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, less invasive treatment option for patients with severe tricuspid valve regurgitation.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in other valve replacement interventions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 5 other locations
- 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 (Recruiting)
- North Shore University Hospital — Manhasset, New York, United States (Recruiting)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Baylor Heart Hospital — Plano, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.