View clinical trials related to Bicuspid Aortic Valve Disease.
Filter by:The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.
To compare down sizing strategy versus annular sizing strategy technique (control group) in Type 0 bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. These aortic complications carry high mortality (>25%) and current management is orientated towards early detection and preventive treatment. Aortic dilation can also result in aortic valve dysfunction leading to heart failure. The estimated UK incidence of aortic disease per year is around 10 per 100,000 individuals, with 2000 people per year dying from aortic complications. The 2017-2020 National Adult Cardiac Surgery Audit report identified the number of people receiving surgery for aortic dissection in Scotland is per population proportionately lower compared to England (4.6 per million per year in Scotland vs. 6.6 per million per year in England). The reasons for this are unclear but may relate to the prevalence of aortic disease or a large geographic distribution with compromised access to specialized centres. Currently surgery is recommended when the aortic diameter exceeds a certain threshold. There are several types of effective surgical procedures, but there is still limited information on their long-term outcomes and the advantage of one procedure over another. The aims of the project are firstly to determine the clinical outcomes of the surgical procedures that are currently employed in Scotland to treat proximal aortic disease and secondly to describe the prevalence and distribution of proximal aortic disease within the Scottish population. The project will be hosted by the Golden Jubilee Research Institute. Contemporary and retrospective data will be collected from all the Scottish Cardiothoracic Surgery units which are based in Glasgow, Edinburgh and Aberdeen. This will be the first study to analyse surgical outcomes for ascending aortic disease in Scotland, and the first to describe the epidemiology of aortic disease within the population. It is anticipated that the results will guide current surgical practise, and provide data to inform national service provision for the management of proximal aortic disease.
The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.
The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.
Bicuspid aortic valve (BAV) is the most common congenital heart anomaly in the general population (1-2% of all individuals). In affected people, the aortic valve (the structure ensuring one way blood flow between the heart's left pumping chamber, the left ventricle and the main body artery, the aorta) consists of 2 rather than 3 leaflets. This arrangement can cause the affected valve to have restricted opening or cause it to leak. Both situations put strain on the heart and patients with BAV across the age range may require surgery to replace the affected valve. BAV is therefore a condition associated with significant ill health and early mortality. BAV is known to cluster in families and is likely to have a genetic cause. We don't fully understand the inheritance of BAV or the specific genes involved in its development. Learning more about this is the basis of the BRAVE study. We will ask patients with BAV and their relatives (who may or may not have BAV) to take part in the study. Blood samples obtained from the participants will be used for analyses of their genetic composition. This information, linked with the clinical data concerning who does and does not have BAV, will potentially enable the identification of the gene changes responsible for the disease. This, we hope, will give us a much better understanding of the mechanisms leading to this serious and common condition.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis. This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract. Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.
Patients with bicuspid aortic valve-related aortopathy are at increased risk of aortic dilatation, dissection and rupture. Currently, risk stratification is largely based on aortic diameter measurements, with those deemed high risk referred for aortic replacement surgery. This approach is imperfect, and potentially exposes many patients to unnecessary high-risk aortic surgery, or fails to identify those at risk of dissection or rupture with smaller diameters. In patients with abdominal aortic aneurysms, the investigators recently demonstrated that uptake of 18F-sodium fluoride predicts disease progression and clinical events independent of aneurysm diameter and standard clinical risk factors. Based on the investigators preliminary data, a study was proposed to look at 18F-sodium fluoride uptake in patients with bicuspid aortic valve-related aortopathy. The proposed study will shed light on the underlying pathological processes involved in aortic complications of this disease as well as potentially providing an important risk marker to predict disease progression and guide the need for major aortic surgery.
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR