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Bicuspid Aortic Valve clinical trials

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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: NCT03836521 Recruiting - Clinical trials for Bicuspid Aortic Valve

Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Start date: August 15, 2016
Phase:
Study type: Observational

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

NCT ID: NCT03635424 Active, not recruiting - Clinical trials for Bicuspid Aortic Valve

Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03495050 Recruiting - Clinical trials for Bicuspid Aortic Valve

BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

BIVOLUTX
Start date: February 21, 2018
Phase:
Study type: Observational [Patient Registry]

Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

NCT ID: NCT03474159 Active, not recruiting - Clinical trials for Bicuspid Aortic Valve

Evaluation of Aortic Stiffness as a Prognostic Indicator of Aortic Dilatation in Patients With Bicuspid Aortic Valve by Multimodal Imaging

IRM-BAO
Start date: November 7, 2018
Phase: N/A
Study type: Interventional

The objective is the development and validation of morphological markers informative of aortic dilatation in order to improve the precision of the risk of aneurysm of the thoracic aorta and of acute aortic syndrome for patients with bicuspid aortic valve (BAV). The primary objective of this study is to demonstrate a correlation between the aortic local pulse wave velocity (PWV) measured with MRI and the progression of the thoracic aorta diameters measured by MRI after a follow-up of 2 years.

NCT ID: NCT03440697 Recruiting - Clinical trials for Aortic Valve Disease

Pathogenetic Basis of Aortopathy and Aortic Valve Disease

TAA
Start date: December 10, 2015
Phase:
Study type: Observational

The main purpose of this study is to define the complex genetic and pathogenic basis of thoracic aortic aneurysm (TAA) and other forms of aortopathy and/or aortic valve disease by identifying novel disease-causing genes and by identifying important genetic modifiers for aortic and aortic valve disease severity.

NCT ID: NCT02917525 Recruiting - Clinical trials for Aortic Valve Stenosis

Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI

BASIK2
Start date: August 2016
Phase: Phase 2
Study type: Interventional

Early development of calcified aortic valve disease (CAVD) is a commonly occurring complication in patients with a bicuspid aortic valve (BAV, an aortic valve consisting of two leaflets instead of three). In general, CAVD is characterized by progressive narrowing of the aortic valve, with involvement of altered calcium metabolism. CAVD progression in fact may lead to necessity of valve replacement, since to date, no other therapies have been shown effective in the treatment of CAVD. The primary objective of our study is to test the hypothesis that supplementation of vitamin K2 will slow down the calcium metabolism in CAVD. Vitamin K2 is essential in the activation of matrix Gla Protein (MGP), an important inhibitory factor in the regulation of calcification. In this randomized controlled trial, 44 patients will be allocated to either the vitamin K2 or placebo group. To assess the calcification process in a detailed manner in these patients, a Positron Emission Tomography (PET) scanner using a tracer (18F-fluoride [NaF]) that has been shown to bind to regions of newly developing microcalcification in aortic valve tissue is used. We expect that vitamin K2 supplementation will reduce the calcium metabolism in the aortic valve on 18NaF-PET (primary endpoint) and slow progression of CAVD as measured by the calcium score on CT and echocardiography after 18 months (secondary endpoints), when compared to placebo.

NCT ID: NCT02899624 Recruiting - Clinical trials for Bicuspid Aortic Valve

Whole Exome Sequencing in Bicuspid Aortic Valve Patients

Start date: January 2014
Phase: N/A
Study type: Interventional

Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies. Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field. The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.

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.