Clinical trials: Bicuspid Aortic Valve (BAV), active
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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 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
Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves.
- Trial name
- NCT06153407
- Where
- South Korea
- Volunteers
- 240 people
- Sponsor
- Yonsei University
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
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
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis, Bicuspid Aortic Valve
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial
The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVE-IT (NCT06817148)
- Testing
- transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cedars-Sinai Medical Center
Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) Registry
The purpose of this registry is to gather information on patients with bicuspid aortic valve disease.
- Trial name
- BAV (NCT01756222)
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Michigan
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, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Bicuspid Aortic Valve Disease
TAVR vs SAVR in Severe Bicuspid Aortic Stenosis
The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).
- Trial name
- BELIEVERS (NCT07413965)
- Testing
- Transcatheter Aortic Valve Replacement, the open chest surgery to replace the aortic valve
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Stenosis With Bicuspid Valve
Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
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)…
- Trial name
- TAILOR-TAVR (NCT05511792)
- Testing
- TAVR for BAV Using Down Sizing with the Evolut Pro platform, TAVR for BAV Using Traditional Sizing strategy with the Evolut Pro platform
- Where
- 15 sites in China
- Volunteers
- 206 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Ascending Aorta Aneurysm, Dilation of the Ascending Aorta
Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
- Trial name
- NCT04372563
- Testing
- aortic prosthetics
- Where
- 2 sites in Russia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Bicuspid Aortic Valve (BAV), Aortic Regurgitation Disease
Towards a More Standardized Bicuspid Aortic Valve Repair: Rationale and Design of CONTOUR Trial - a Randomized Trial
Background: Between one-third and one-half of patients with bicuspid aortic valve (BAV) disease develop significant aortic regurgitation (AR) at a young age, leading to cardiomyopathy and heart failure.
- Trial name
- CONTOUR (NCT06869954)
- Testing
- Internal HAART 200 annuloplasty device, double external ring annuloplasty
- Where
- 4 sites in Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital Augsburg
Bicuspid Aortic Valve
Identification of Genetic Causes of Bicuspid Aortic Valve Disease
BAVgenetics is a partnership between Investigators at Boston University, Brigham and Women's Hospital, and Massachusetts General Hospital dedicated to discovering the genetic causes of bicuspid aortic valve disease and associated…
- Trial name
- BAV Genetics (NCT01026571)
- Where
- United States
- Volunteers
- 11,000 people, healthy volunteers welcome
- Sponsor
- Boston University
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
Ascending Aortic Aneurysm
A Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves.
Ascending aortic aneurysms (AAAs) are serious conditions that can lead to aortic dissections or ruptures, carrying a high risk of mortality.
- Trial name
- PROMETA (NCT07695545)
- Testing
- Additional blood samples, Collection of discarded ascending aortic tissue
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Bicuspid
Prospective 4D CTA of BAV Competence
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…
- Trial name
- NCT04645862
- Testing
- CT scans
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Pennsylvania
Aortic Dissection
Nordic Consortium for Acute Type A Aortic Dissection-2
The Nordic Consortium for Acute Type A Aortic Dissection-2 (NORCAAD-2) is a multicenter research collaboration involving up to 19 units in the Nordic countries and one in The Netherlands.
- Trial name
- NORCAAD-2 (NCT06862583)
- Testing
- surgery, endovascular intervention
- Where
- Sweden
- Volunteers
- 5,000 people
- Sponsor
- Karolinska Institutet
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