Transcatheter Valve Replacement for Tricuspid Regurgitation
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should be adequately treated for heart failure, which might imply continuing some medications. Please consult with the trial team for specific guidance.
Is transcatheter valve replacement for tricuspid regurgitation safe?
The safety of transcatheter tricuspid valve replacement (TTVR) has been evaluated in patients with severe tricuspid regurgitation, showing it to be a promising option for high-risk patients. While specific safety data for the inQB8 TTVR System is not mentioned, TTVR in general is emerging as a safe alternative to traditional surgery, which has high risks.12345
How is the inQB8 TTVR System treatment different from other treatments for tricuspid regurgitation?
The inQB8 TTVR System is a transcatheter valve replacement treatment, which means it is a minimally invasive procedure that replaces the tricuspid valve without open-heart surgery. This approach is particularly beneficial for high-risk patients who may not be suitable for traditional surgical methods, offering a safer alternative with potentially lower recovery times.12346
What is the purpose of this trial?
Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
Eligibility Criteria
This trial is for individuals with severe or greater tricuspid valve regurgitation, who are stable and have been treated for heart failure. They must be anatomically suitable for the MonarQ TTVR System. Those in other studies, needing urgent surgery, or with refractory heart failure requiring advanced intervention cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- inQB8 TTVR System
Find a Clinic Near You
Who Is Running the Clinical Trial?
inQB8 Medical Technologies, LLC
Lead Sponsor