This trial is evaluating whether Edwards Cardioband System will improve 1 primary outcome and 5 secondary outcomes in patients with Mitral Valve Insufficiency. Measurement will happen over the course of 30 days.
This trial requires 375 total participants across 2 different treatment groups
This trial involves 2 different treatments. Edwards Cardioband 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.
"Mitral stenosis is caused by valve thickening due to calcific deposits, which alter the normal functioning of the valve. Mitral insufficiency can cause valvular stress and abnormal heart function, but other causes should be ruled out." - Anonymous Online Contributor
"With appropriate management, mitral insufficiency is a relatively benign condition and can be cured by surgical repair or valve replacement with or without concomitant aortic valve repair." - Anonymous Online Contributor
"The mitral valve performs two important roles in the heart. First, it separates the two main blood-producing chambers, the left atrium and the right ventricle. Second, it prevents blood from flowing backward from the ventricle into the backward-flowing left atrium. With a properly-functioning mitral valve, these important functions are performed by valves attached to the mitral valve. But with a mitral valve that becomes obstructed by a gradual calcification, blood is able to flow backward from the ventricle into the atrium and the left ventricle is no longer filled with oxygen-rich blood." - Anonymous Online Contributor
"About 2 million people experience mitral insufficiency or regurgitation in the United States each year. This is 2.1% of the U.S. population. Half of the people experience valve regurgitation. About 10-13% of the population experienced a cardiac event related to mitral regurgitation (regurgitation or sudden deaths) in the U.S. in the past year. About 50% of the people who get mitral regurgitation experience other valve diseases, such as leaflet tears. Most people with mitral insufficiency or regurgitation can live with their disease." - Anonymous Online Contributor
"Given the limitations of surgical outcomes, percutaneous approaches will continue to play a vital role for patients with mitral leakage and will remain a first-line treatment." - Anonymous Online Contributor
"Signs and symptoms of mitral valve insufficiency include a palpable second heart sound, tachycardia, chest pain and palpitations. There is a slight increase in transmitral pressure gradient with exercise." - Anonymous Online Contributor
"The primary cause of mitral insufficiency is mitral regurgitation, either in a congenital or acquired setting. Mitral insufficiency may be a late clinical finding in some patients who have a cardiomyopathy. Mitral insufficiency may also be the explanation for cardiomyopathies in patients with no dilated left ventricle and no systolic or diastolic abnormality on clinical examination." - Anonymous Online Contributor
"Patients with symptomatic ischemic mitral regurgitation may present with impaired cardiac reserve and left ventricular function. However, in the absence of any other evidence of underlying cardiac disease, the prognosis for patients with ischemic mitral regurgitation appears favorable. The treatment of choice for ischemic mitral regurgitation remains repair if possible." - Anonymous Online Contributor
"Age is an important determinant for the occurrence of mitral valve dysfunction in this population. Mitral insufficiency is associated with more atherosclerotic disease in the coronary arteries and a higher incidence of myocardial infarction." - Anonymous Online Contributor
"In most cases of mitral stenosis and mitral insufficiency, the use of BMS with another treatment option is not more effective than using a combination of other treatment options. There may be individual cases where this approach is a reasonable option." - Anonymous Online Contributor
"MVI is not a hereditary disease, since no evidence of genetic defect was seen by family history analysis. Although MVI occurs in 1% of the general population, its occurrence in family members seems to be the result of some unknown environmental factor(s)." - Anonymous Online Contributor
"The balloon was successfully placed in 97 % of patients and, when placed under appropriate conditions, is a low-risk intervention that provides a good result with minimal morbidity or mortality." - Anonymous Online Contributor