Clinical trials: Bicuspid Aortic Valve
Bicuspid Aortic Valve
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular…
- Trial name
- NCT06375590
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Didier TCHETCHE
Cardiovascular Diseases
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
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…
- Trial name
- BRAVE (NCT04514445)
- Testing
- Observational
- Where
- 4 sites in United Kingdom
- Volunteers
- 700 people
- Sponsor
- University Hospitals, Leicester
Bicuspid Aortic Valve, Aortic Valve Stenosis
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients…
- Conditions
- Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases
- Trial name
- ARDITAV (NCT05708118)
- Testing
- Echocardiographic assessment., Computed-tomography assessment
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Aortopathies, Thoracic Aortic Aneurysm
Pathogenetic Basis of Aortopathy and Aortic Valve Disease
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…
- Conditions
- Aortopathies, Thoracic Aortic Aneurysm, Aortic Valve Disease, Thoracic Aortic Disease
- Trial name
- TAA (NCT03440697)
- Where
- 2 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Yale University
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Valve Stenosis
Ascending Aortic Dilation in BiAV After TAVR
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
- Trial name
- NCT03051334
- Testing
- diagnosed as bicuspid aortic valve
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Seoul National University Hospital
Bicuspid Aortic Valve (BAV)
A Study of Chinese Congenital Bicuspid Aortic Valve
Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV.
- Trial name
- NCT06802016
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Ruijin Hospital
Aortic Stenosis, AORTIC VALVE DISEASES
A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy.
- Trial name
- ASCENT (NCT07450196)
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Bicuspid Aortic Valve
The CASPER Registry
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…
- Trial name
- NCT04817735
- Testing
- TAVI
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Pisa
Aortic Valve Stenosis, Cardiovascular Diseases
The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.
- Conditions
- Aortic Valve Stenosis, Cardiovascular Diseases, Heart Valve Diseases, Bicuspid
- Trial name
- Bicuspid TAVR (NCT02394184)
- Testing
- transcatheter aortic valve replacement
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Seung-Jung Park
Aortic Stenosis With Bicuspid Valve
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection
The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).
- Trial name
- NCT05844969
- Where
- 4 sites in United Kingdom
- Volunteers
- 140 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Thoracic Aortic Aneurysm, Bicuspid Cardiac Valve
Indexed Aortic Area in Bicuspid Aortic Valve Aortopathy
This study aims to determine the relationship between the cross-sectional aortic area/patient height ratio (indexed aortic area) and absolute aortic diameter in proximal thoracic aortic aneurysms associated with a bicuspid valve.
- Trial name
- NCT04756778
- Testing
- Aortic surgery +/- aortic valve replacement
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- St. George's Hospital, London
Bicuspid Aortic Valve
A Multicentre Retrospective Study on Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners.
- Trial name
- NCT05818722
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Bicuspid Aortic Valve
Whole Exome Sequencing in Bicuspid Aortic Valve Patients
Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three.
- Trial name
- NCT02899624
- Testing
- Extra blood draw samples, additional tissue samples
- Where
- France
- Volunteers
- 427 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
Bicuspid Aortic Valve
Evaluating the Effectiveness of Atorvastatin on the Progression of Aortic Dilatation and Valvular Degeneration in Patients With Bicuspid Aortic Valve
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.
- Trial name
- BICATOR (NCT02679261)
- Testing
- Atorvastatin
- Where
- 10 sites in Spain
- Volunteers
- 220 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
AORTIC VALVE DISEASES, Bicuspid Aortic Valve (BAV)
Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China
Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study
- Trial name
- NCT06830499
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 4 sites in China
- Volunteers
- 450 people
- Sponsor
- Xijing Hospital
Bicuspid Aortic Valve
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
- Trial name
- BIVOLUTX (NCT03495050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Clinique Pasteur
Bicuspid Aortic Valve, Thoracic Aortic Aneurysm
Assessment of Risk in Thoracic Aortopathy Using 18F-Sodium Fluoride
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…
- Conditions
- Bicuspid Aortic Valve, Thoracic Aortic Aneurysm, Aortic Dissection
- Trial name
- AoRTAS (NCT04083118)
- Testing
- clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI, Repeat 18F sodium fluoride PET/MRI
- Where
- United Kingdom
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- University of Edinburgh
Aortic Stenosis
Role of Elastin Metabolites in Aortic Remodelling in AS
Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age.
- Trial name
- ELASTIC-AS (NCT03883490)
- Testing
- ECG, Blood test and biobanking, Trans-thoracic Echocardiogram
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- University of Leicester
Aortic Stenosis, Ascending Aortic Dilatation
Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1.
- Conditions
- Aortic Stenosis, Ascending Aortic Dilatation, Bicuspid Aortic Valve
- Trial name
- NCT05739253
- Testing
- Transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 480 people
- Sponsor
- China National Center for Cardiovascular Diseases