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Bicuspid Aortic Valve clinical trials

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NCT ID: NCT05836363 Completed - Clinical trials for Bicuspid Aortic Valve

Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Start date: December 4, 2020
Phase:
Study type: Observational

Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications. There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract. The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.

NCT ID: NCT04083118 Completed - Aortic Dissection Clinical Trials

Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride

AoRTAS
Start date: April 1, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT02679261 Completed - Clinical trials for Bicuspid Aortic Valve

Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve

BICATOR
Start date: June 2016
Phase: Phase 3
Study type: Interventional

Bicuspid Aortic Valve (BAV) is the most common congenital heart disease affecting 1-2% of the population. The aortic dilation and aortic valve degeneration are common complications in patients with BAV. Statins have shown a reduction in the expression of metalloproteinases of the extracellular matrix observed in aortic aneurisms. Several retrospective studies have suggested the benefit of the statins to reduce aortic dilation in patients with BAV. Moreover, although statins did not show to be useful in the progression of aortic stenosis, different studies have suggested a higher profit when the valve affection is not severe. The objective of this study is to determine whether atorvastatin is effective at reducing the progression of aortic dilation in patients with BAV.

NCT ID: NCT02283970 Completed - Clinical trials for Aortic Regurgitation

Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)

VAR
Start date: December 2012
Phase:
Study type: Observational

Prospective longitudinal study on four small groups of surgical patients affected by: BAV with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with isolated stenosis in over 60 year-old patients. The aim of the study is to select homogeneous small groups of surgical patients with the same subtype of BAV and same aortic behaviour and identify markers/predictors of favorable-unfavorable aortic wall evolution to evaluate if there is a BAV phenotype more likely to be considered at high risk for aortic degeneration.

NCT ID: NCT01920815 Completed - Clinical trials for Bicuspid Aortic Valve

Bicuspid Valve Aortopathy Feasibility Study

Start date: July 2013
Phase:
Study type: Observational [Patient Registry]

In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.

NCT ID: NCT01823432 Completed - Clinical trials for Bicuspid Aortic Valve

Genetic Risks for Bicuspid Aortic Valve Disease

Start date: March 2012
Phase:
Study type: Observational [Patient Registry]

Bicuspid Aortic Valve (BAV) is the most common congenital heart malformation in adults, but very little is known about the genetic causes or risk factors for adverse outcomes. Currently, it is estimated that most cases of aortic stenosis in patients less than 65 years old are caused by BAVs. BAV patients are also at high risk to develop aneurysms of the ascending aorta, which may lead to aortic dissections. Dr. Prakash and his colleagues plan to use individual genetic information to identify persons with BAV who are at high risk for complications and to customize therapies.

NCT ID: NCT01760668 Completed - Turner Syndrome Clinical Trials

Aortopathy in Persons With Bicuspid Aortic Valve, Turner and Marfan Syndrome

Start date: February 2013
Phase: N/A
Study type: Observational

The study aim is: 1. To examine aortic tissue by light microscopy 2. To examine aortic tissue by electron microscopy 3. To study changes in the epigenome and transcriptome of the X chromosome specific to aortic tissue. 4. To examine aortic tissue using biochemistry including proteomics. 5. To establish the karyotype of fibroblasts with standard chromosome examination on 10 meta-phases as well as by fluorescent in situ hybridization (FISH) with probes covering the X and Y chromosome. Using the latter 200 meta-phases will be examined. 30 controls who did not die from aortic dissection or dilation will be recruited from The Department of Forensic Medicine at Aarhus University Hospital. The investigators will subject samples of aortic tissue from women undergoing prophylactic aortic surgery due to either Marfan syndrome or bicuspid aortic valve to the same panel of examinations (except karyotyping). Lastly the investigators will compare the results from the three groups (Turner syndrome, Marfan syndrome and Bicuspid aortic valve).

NCT ID: NCT00412386 Completed - Clinical trials for Congenital Heart Disease

Abnormal 3-D MRI Flow Patterns in Adolescents Patients With Bicuspid Aortic Valve

Start date: December 2006
Phase: N/A
Study type: Observational

Bicuspid aortic valve (BAV) is a form of congenital heart disease (the person is born with it). With BAV, the heart valves in the aorta (the blood vessel that takes blood away from the heart to the body) are not formed right. A person with BAV has only 2 leaflets instead of three and the valve leaflets are often thickened. This can result in the block of blood flow across the valve (aortic stenosis) and/or valve leakage (aortic valve regurgitation). From our experience at least 1/3 of patients with BAV will eventually develop complications. Many patients with BAV do not develop significant problems until well into adulthood. The most common problem in BAV patients is aortic dilatation and/or dissection. At this point, we do not know on who or why aortic dilatation or dissection occurs.It is unclear whether the enlargement is because of abnormal blood flow patterns, as a result of the shape of the bicuspid valve, or whether it is because the way the aortic valve and/or vessel is formed. In other words, the abnormal shape of the aortic valve may cause blood to flow in a different way than it normally would, causing damage to the aorta as blood leaves the heart. There may be a problem with the way the aortic valve connects to the aorta, which causes the aorta to get larger or break down over time. It is also possible that the wall of the aorta in patients with BAV is weaker than it would be in patients without BAV. At this point, we do not know. It is believed by the investigators that if we can determine why the aorta gets larger or tears, we can minimize the effects or prevent them altogether. This study will collect blood and cardiac MRI images from forty-five (45) patients at Children's Healthcare of Atlanta Egleston. There will be a study group (patients with BAV) and a control group of patients (patients scheduled for a cardiac MRI but without BAV). All enrolled patients will have blood drawn by nursing staff from a peripheral vein and collected in tubes for testing the day of their MRI scan. This test is called a plasma matrix metalloproteinase level. It is believed that patients who have bicuspid aortic valves and dilated aortas have high plasma levels of this protein. This study will compare the MRI images and plasma matrix protein levels of all the patients participating in the study.