This trial is evaluating whether Portico transcatheter aortic valve will improve 3 primary outcomes and 6 secondary outcomes in patients with Aortic Valve Stenosis. Measurement will happen over the course of 30 days from index procedure.
This trial requires 1150 total participants across 4 different treatment groups
This trial involves 4 different treatments. Portico Transcatheter Aortic Valve is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"Individuals with aortic stenosis may have sudden abnormal heart sounds, dizziness, and orthopnea. Complications can include aortic dissection, pulmonary embolism, and cardiac arrest. Severe aortic stenosis can affect one or more heart valves and often affects the aortic valve only. The aortic valve, being small and complex, is the most affected of all valves. Individuals with aortic stenosis should be evaluated for their risk of heart valve disease." - Anonymous Online Contributor
"Aortic stenosis is the most common valvular disease in the community. There are significant and varied symptoms that can manifest as patients with aortic stenosis seek medical attention. Physicians must be aware of aortic stenosis presentations when evaluating patients with different symptoms, especially in the elderly and for individuals that have an atypical chest pain. To identify the initial presentation of aortic stenosis, the [Chest Pain Society Guidelines for Aortic Stenosis] are summarized in this article. A detailed medical history and physical examination and specific laboratory tests can help to establish whether aortic stenosis or another diagnosis is more likely. Further evaluation may involve echocardiography." - Anonymous Online Contributor
"The high prevalence of aortic stenosis in United States population and lower rate of surgical repair indicates the need for improved access to timely surgical treatment of aortic stenosis." - Anonymous Online Contributor
"The data from this study do not support the view that valve surgery can cure aortic stenosis. Although symptomatic improvement may be achieved in the majority of treated patients and this is a good indication in these patients, one-third of these patients will have a recurrence of symptoms within 5 years. These patients will have to be followed up regularly." - Anonymous Online Contributor
"The most common treatment for aortic stenosis is cardiovascular replacement surgery. A variety of techniques such as the Ross operation, Ross-Konno, and St. Jude-DeBakey valve replacement procedures are used. However, valve replacement surgery is highly dependent on patient age, comorbidities, and other patient and surgeon specific factors. Although no cure is evident, valvular heart disease is highly treatable." - Anonymous Online Contributor
"Besides its usual congenital cause, aortic stenosis is multifactorial. Its aetiology is largely unknown in patients ≤ 50 years of age; however, the increase in patients ≥ the age of 50 years causes an increase in the aetiology of aortic stenosis. Moreover, the increase in the number of patients with aortic stenosis was explained by an increase in congenital aortic stenosis, but also by the increase in the number of patients who develop this disease after the age of 50 years." - Anonymous Online Contributor
"In a recent study, findings suggest that the use of TAV in patients with AVS is rare in the United States. The current guidelines for TAV are mostly focused on patients with severe AS who are expected to have profound valve obstruction and to receive high-risk surgical therapy. There is a paucity in our database of patients treated with TAV in combination with other treatments." - Anonymous Online Contributor
"The most common complications were minor, and were not considered serious by the patients. The most common side effects were local bleeding, transient ischemic attacks, and minor neurologic disturbances." - Anonymous Online Contributor
"In this cohort of aortic stenosis patients from a United Kingdom center, the proportion receiving a clinical trial was low (15%). Most patients received conservative management and did not meet criteria for a formal randomized trial, but some patients were excluded from clinical trials, particularly those who were underweight or who were younger and/or had no concomitant risk factor. These conclusions are limited if they are transferable to other centers or countries. Further studies are required to identify and resolve specific barriers to clinical trial participation." - Anonymous Online Contributor
"The primary cause of aortic valve stenosis is thought to be a structural abnormality (such as thickening) of valvular interstitial tissue, rather than a change of cardiac function (as may be the case with aortic regurgitation)." - Anonymous Online Contributor
"In the TIPS-PTAVS comparison, the study results indicate a reduction of TTRs and an improvement of the NYHA functional class. In our study, the authors found a significant decrease of the number of endovascular interventions and procedural length." - Anonymous Online Contributor
"Although research results have become more frequent lately, there are still some doubts regarding the validity of some of these trials. Patients with bioprosthetic aortic valves should be followed up with regular echocardiograms and they should receive additional preventive therapies, and aortic valve stenosis should be considered in the list of indications for surgery." - Anonymous Online Contributor