Transcatheter Valve Intervention for Tricuspid Regurgitation
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be on an optimal dosage of diuretics as determined by the investigator.
What data supports the effectiveness of the treatment LuX-Valve Plus System for tricuspid regurgitation?
Research shows that the LuX-Valve treatment significantly improved symptoms in patients with severe tricuspid regurgitation, with most patients experiencing reduced valve leakage and better heart function. In a study, 11 out of 12 patients had successful outcomes, and their quality of life improved without major complications.12345
Is the LuX-Valve system safe for treating tricuspid regurgitation?
The LuX-Valve system has been shown to be generally safe for treating severe tricuspid regurgitation, with studies reporting successful procedures and significant improvement in patients' symptoms. In a study of 12 patients, there were no device-related complications, and most patients experienced improved quality of life.12367
How is the LuX-Valve Plus treatment different from other treatments for tricuspid regurgitation?
The LuX-Valve Plus is unique because it is a transcatheter valve replacement system that does not rely on radial force, making it a promising alternative for patients who are at high risk for open-heart surgery. It is implanted through a minimally invasive approach, which can significantly improve symptoms and quality of life for patients with severe tricuspid regurgitation.12358
What is the purpose of this trial?
The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).
Eligibility Criteria
This trial is for adults over 18 with severe heart murmur or tricuspid valve regurgitation, who are symptomatic but considered unsuitable for surgery by a Heart Team. They must understand the study and consent to participate, be on stable diuretic medication, and have their condition confirmed by specialized labs.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the LuX-Valve Plus System for the treatment of severe tricuspid regurgitation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are monitored for long-term safety and effectiveness
Treatment Details
Interventions
- LuX-Valve Plus System
LuX-Valve Plus System is already approved in China, United States, European Union for the following indications:
- Severe tricuspid regurgitation (TR)
- Severe tricuspid regurgitation (TR)
- Severe tricuspid regurgitation (TR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jenscare Innovation Inc.
Lead Sponsor
Cardiovascular Research Foundation, New York
Collaborator