This trial is evaluating whether Portico™ NG (Navitor) Valve and FlexNav™ Delivery System will improve 2 primary outcomes and 1 secondary outcome in patients with Aortic Valve Stenosis. Measurement will happen over the course of at 30 days.
This trial requires 399 total participants across 2 different treatment groups
This trial involves 2 different treatments. Portico™ NG (Navitor) Valve And FlexNav™ Delivery System is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"The portico valves continue to advance with improved efficacy. Flexnav valve has also shown superiority at higher left ventricular pressures, especially in patients with low EF." - Anonymous Online Contributor
"Even if aortic stenosis has become asymptomatic, it is still a medical emergency and is still associated with a relatively high risk of death. Surgical treatment should be recommended to prevent further complications." - Anonymous Online Contributor
"AS and aortic insufficiency are both associated with an increased risk for stroke. AS in women, particularly those older than 60 y at presentation, is associated with an increased risk for stroke. AS may occur with aortic insufficiency. In women, concomitant aortic insufficiency with severe pulmonary valve stenosis is associated with an almost 30% risk of stroke, while concomitant severe pulmonary stenosis with severe aortic insufficiency only has a 12% risk of stroke." - Anonymous Online Contributor
"The common treatments for mitral and/or aortic valvular stenosis are similar in the management of patients. Aortic valve replacement is now performed in most patients. However, the timing of surgery in those with comorbid mitral stenosis remains unclear. Surgery should be performed at the time when the patient is symptomatic, as long-term risk is high." - Anonymous Online Contributor
"Though the causes are likely multifactorial, a genetic component to BAVS is considered likely and further investigation is warranted. Aortic valve stenosis is more common in women than in men, suggesting that women are more susceptible to this condition than men. There is an association between BAVS and hypertension, which may have a genetic basis." - Anonymous Online Contributor
"Aortic stenosis can be suspected on the clinician's basis only in the presence of heart murmurs that are of a pulsus type and in the absence of other features, i.e., syncope in young males with high-powered cardiac murmur. Echocardiography is the most important tool for diagnosing aortic stenosis and evaluating the severity of AS on a clinical basis; however, blood pressure and murmur intensity should also be examined. There are many symptoms and signs of aortic stenosis and if they are not present, it may be difficult to diagnose the disease solely on the basis of history and physical examination alone." - Anonymous Online Contributor
"Patients who have aortic stenosis are likely to be older, female, and of lower socioeconomic status than patients with coronary artery disease. As the number of patients with aortic stenosis increases, the number of patients with severe coronary artery disease may suffer a decrease. The National Heart, Lung and Blood Institute's criteria may represent a compromise among different stakeholders." - Anonymous Online Contributor
"In our study, combined use of n-ng valve with other procedures for patients with severe aortic stenosis did not achieve better results than either valve alone. Based on our findings, if a patient is planned to receive only one valve, we recommend that a non-valved device be reserved for this patient population." - Anonymous Online Contributor
"As a transcatheter closure device, with which are you more likely to find yourself, the NaviceSpring Flexnav DS and the Portico Navice NT and Ng (naviter) valve appear effective, and have demonstrated excellent or very good results in small randomized clinical studies. These devices have been adequately validated through comparative studies, large-scale observational studies, and large randomized placebo-controlled studies. In summary, the devices and devices were effective in improving clinical outcomes and were associated with low rates of serious endoleaks. The devices offer a valid alternative to surgical aortic valve replacement and can therefore provide a favorable alternative for patients who otherwise would not be eligible for aortic valve replacement." - Anonymous Online Contributor
"Our report is the first to describe the safety of portico™ ng (navitor) valve and flexnav™ delivery system in 5 patients, and highlights possible hazards of both devices." - Anonymous Online Contributor
"The outcomes of the authors' experience with the Portico™ NG / Flexnav™ delivery device in valve-in-valve patients with bicuspid aortic valve disease are very favorable. The authors' findings support the need for large-scale validation of this strategy for aortic valve implantation with bicuspid aortic valve disease." - Anonymous Online Contributor
"The most common side effects were related to the device type that was used. Results from a recent clinical trial is unique in its use of the Portico MVS system. To the best of our knowledge, there are no reports of use of this system with a non-inferior mitral valve, [even though most patients in the Portico group are on long-term warfarin treatment] in humans. The Portico System should be used in patients with mitral stenosis undergoing surgical valve replacements. However, patients receiving this device could be instructed to take all medicines regularly, such as warfarin." - Anonymous Online Contributor