BridgeMD
New treatment option for Tricuspid Regurgitation (TR)
Official title Robotic Transjugular Transcatheter Tricuspid Valve Replacement
ClinicalTrials.gov ID: NCT07516145
What this study is testing
- What it's testing
- Valvular heart disease (VHD), caused by abnormalities in heart valves, can lead to severe complications such as heart failure and death, with approximately 220 million affected patients worldwide. The prevalence of VHD continues to grow alongside the aging global population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age 18-90
- Severe symptomatic TR
- Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac...
- Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system
- Able to consent
You likely can't join if
- Prior TV repair or replacement that would interfere with Lux-valve plus implantation
- severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mm Hg or \>2/3 systemic with pulmonary vascular resistance \>5 WU after...
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative...
- Left Ventricular Ejection Fraction (LVEF) \<40% or;
- Evidence of intracardiac mass, thrombus or vegetation or;
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;
See the full eligibility criteria
- Age 18-90
- Severe symptomatic TR
- Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and
- Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system
- Able to consent
- Prior TV repair or replacement that would interfere with Lux-valve plus implantation
- severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mm Hg or \>2/3 systemic with pulmonary vascular resistance \>5 WU after vasodilator challenge)
- Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy
- Left Ventricular Ejection Fraction (LVEF) \<40% or;
- Evidence of intracardiac mass, thrombus or vegetation or;
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;
- Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation); people with concomitant valvular disease may treat their...
- Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or;
- Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or;
- Underwent any cardiac or non-cardiac treatment or surgical procedure within 30 days prior to the procedure or planned to have the treatment or surgical procedure within 60 days after implant procedure (e.g...
- Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
- Life expectancy is less than 1 year;
- Current participation in another investigational drug or device study.
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, Hong Kong
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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.