Tricuspid Valve Repair System for Tricuspid Valve Insufficiency
This study is evaluating whether a new device can improve heart function in people with heart valve disease.
See full descriptionAbout the trial for Tricuspid Valve Insufficiency
Treatment Groups
This trial involves 2 different treatments. Tricuspid Valve Repair System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Tricuspid Valve Repair System will improve 3 primary outcomes and 3 secondary outcomes in patients with Tricuspid Valve Insufficiency. Measurement will happen over the course of At 30 days.
Patient Q & A Section
How does tricuspid valve repair system work?
TAVR is a new technique for treating severe tricuspid valve insufficiency with few complications. Although these patients are younger than is previously thought, there is still an elderly percentage of TAVR patients.
What are common treatments for tricuspid valve insufficiency?
Tricuspid valve regurgitation in adults occurs in 1.7-3.6% of the population. More than 90% of those affected require some sort of intervention for valve incompetence; surgical repair is the preferred approach. Although transcatheter interventions are growing in popularity in developed regions, their routine use remains limited. More than 50% of the patients will require subsequent concomitant surgeries.
What is tricuspid valve insufficiency?
TR is a disorder of the tricuspid valve which reduces the normal blood flow from the left ventricle of the heart into the right ventricle. At any time tricuspid stenosis (TRS) may develop. This will eventually lead to pulmonary hypertension and functional heart failure. Inappropriate tricuspid regurgitation (TRR) leads to ventricular dysfunction, and has adverse health hazards.
What causes tricuspid valve insufficiency?
Valvular lesions are an extremely common cause of tricuspid valve insufficiency. Mitral valve insufficiency can also generate this type of valvular effect, but its diagnosis remains elusive.
What are the signs of tricuspid valve insufficiency?
The signs of tricuspid regurgitation are low-grade tricuspid insufficiency, low-voltage murmurs, right mainstem bundle thrombosis and tricuspid annulus enlargement. Echocardiography should detect these signs and allow the diagnosis of tricuspid regurgitation in case of mild symptoms.
How many people get tricuspid valve insufficiency a year in the United States?
Nearly 3 million elderly people have insufficiency of the tricuspid valve. This information may be useful for future discussion of the role of echocardiography in clinical practice.
Can tricuspid valve insufficiency be cured?
Most patients with functional regurgitation of the tricuspid valve (tricuspid insufficiency) can be cured by the Ross operation, and can be spared a life-threatening operative morbidity.
What are the common side effects of tricuspid valve repair system?
Tricuspid Valve Repair System has been used since 2000 in Germany. There was no statistically significant difference in the incidence of pericardial effusion or tamponade. We can tell, that the intra-pericardial implantation of TMR systems is not associated with higher incidence and severity of pericardial effusion and tamponade.
Have there been any new discoveries for treating tricuspid valve insufficiency?
There is still much discussion and research needed to better understand and treat tricuspid stenosis. It is evident that tricuspid regurgitation does not respond as well to therapies known to treat mitral and aortic stenosis. It is also important not to forget the unique needs of patients with rheumatic pathology whose heart valves often must be compromised or valvulotomized in order to prevent further damage. As a result, it is very important to remember the patient's unique case before considering different treatment modalities. It is also important to take into account the need for a detailed transthoracic echocardiogram.
What is the primary cause of tricuspid valve insufficiency?
[Primary mitral valve regurgitation is a far more frequent cause of TR than previously believed. TR secondary to a ndisrupting annular commissure in the anterior interventricular groove is a nodal source of TR]]
Who should consider clinical trials for tricuspid valve insufficiency?
All patients with severe TAVD and severe LVSD have a large subpopulation who have no potential for treatment with a therapeutic drug and may have a poor outcome. All patients with severe TAVD should be considered for clinical trials because these patients may have an elevated risk of serious cardiac events at the time of enrollment.
Does tricuspid valve repair system improve quality of life for those with tricuspid valve insufficiency?
Although TAVI with TV repair system has an acceptable immediate operative risks and midterm survival, midterm survival has not yet been proven long-term. Although a patient can expect to be asymptomatic after operation, a deterioration in HRQoL is anticipated when a patient lives with TrS. The patients will be expected to cope with new symptoms and have improved HRQoL. TAVI with TV repair system is an effective treatment options for TrS and is still awaited to clarify its long-term survival outcomes by randomized controlled trials.