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New treatment option for Tricuspid Valve Regurgitation
Official title Clinical Study of the inQB8 TTVR System (The MonarQ Study)
ClinicalTrials.gov ID: NCT06611579
What this study is testing
- What it's testing
- Prospective, multi-center study to assess safety and performance of the inQB8 MonarQ Tricuspid Valve Replacement System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Thousand Oaks, California, United States
- Atlanta, Georgia, United States
- Manhasset, New York, United States
- Philadelphia, Pennsylvania, United States
- Plano, Texas, United States
- Bruges, Belgium
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Thousand Oaks, California, United States; Atlanta, Georgia, United States; Manhasset, New York, United States; Philadelphia, Pennsylvania, United States; Plano, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.