50 Participants Needed

Transcatheter Valve Replacement for Tricuspid Regurgitation

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: inQB8 Medical Technologies, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Anatomically suitable for the MonarQ TTVR System
I have severe symptoms from heart valve leakage.
My heart and blood pressure are stable.
See 1 more

Exclusion Criteria

Currently participating in another investigational biologic, drug or device study
Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up
I do not need any urgent surgeries, including heart surgery in the next year or heart procedures in the next 3 months.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year
Multiple visits at 30 days, 6 months, and 1 year

Treatment Details

Interventions

  • inQB8 TTVR System
Trial Overview The study is testing the safety and performance of a new device called the inQB8 MonarQ Tricuspid Valve Replacement System through a procedure known as transcatheter tricuspid valve replacement at multiple centers.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System

Find a Clinic Near You

Who Is Running the Clinical Trial?

inQB8 Medical Technologies, LLC

Lead Sponsor

Trials
1
Recruited
50+

Findings from Research

Transcatheter tricuspid valve replacement (TTVR) was performed successfully in 46 high-risk patients with severe tricuspid regurgitation, achieving a procedural success rate of 97.8% and significantly reducing the severity of TR after 6 months.
The procedure demonstrated a favorable safety profile, with a 6-month mortality rate of 17.4% and a significant reduction in symptoms like peripheral edema and ascites, indicating improved patient outcomes.
Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation.Lu, FL., An, Z., Ma, Y., et al.[2021]
In a study of 28 patients with severe tricuspid regurgitation, the edge-to-edge transcatheter tricuspid valve repair (TTVr) successfully reduced tricuspid regurgitation by at least one grade in all patients, demonstrating high efficacy.
At three months post-procedure, 83% of patients improved to NYHA class I or II, and only one patient experienced a minor complication, indicating that TTVr is a safe and effective treatment option for severe tricuspid regurgitation.
Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program.Cepas-Guillen, PL., de la Fuente Mancera, JC., Guzman Bofarull, J., et al.[2021]
In a study of 80 patients with symptomatic tricuspid regurgitation treated with either the PASCAL or MitraClip-XTR device, both systems showed similar effectiveness in reducing TR severity, with 91% of PASCAL patients and 96% of MitraClip-XTR patients achieving at least a one-grade reduction at 30 days.
Both devices were found to be safe, with no periprocedural deaths and comparable 30-day and 3-month mortality rates, indicating that TTVR is a viable option for high-surgical-risk patients.
PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis.Sugiura, A., Vogelhuber, J., Öztürk, C., et al.[2021]

References

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. [2021]
Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. [2021]
PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. [2021]
Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies. [2023]
Long-Term Outcomes of the FORMA Transcatheter Tricuspid Valve Repair System for the Treatment of Severe Tricuspid Regurgitation: Insights From the First-in-Human Experience. [2020]
The TriClip system for edge-to-edge transcatheter tricuspid valve repair. A Spanish multicenter study. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security