Assessment of the inQB8 Tricuspid Valve Replacement System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Lead-related tricuspid valve leakage after first-time pacemaker or ICD implantation

  This project will see if a new transvenous pacemaker or ICD lead causes new or worse tricuspid valve regurgitation in people getting their first device.

  Recruiting Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW · Bad Oeynhausen, North Rhine-Westphalia · NCT07342036

• Tracking progression and consequences of heart valve disease

  This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

  Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

• Evaluating a new device for replacing the tricuspid valve in patients with severe regurgitation

  This study is testing a new device to replace the tricuspid valve in adults with severe regurgitation who can't have traditional surgery to see if it is safe and works well.

  Recruiting at 6 sites TRiCares · Aalst and 7 other locations · NCT06581471

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.