Clinical trials: Bicuspid Aortic Valve Disease, open to volunteers
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
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
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
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
Bicuspid Aortic Valve (BAV)
Size Up Bicuspid With the LIra MEthod: the SUBLIME Study
Transcatheter aortic valve replacement (TAVR) outcomes in patients with raphe-type bicuspid aortic valve (BAV) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation.
- Trial name
- SUBLIME (NCT06657911)
- Where
- 5 sites in Italy, Switzerland
- Volunteers
- 250 people
- Sponsor
- IRCCS San Raffaele
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
Aortic Aneurysm, Aortic Dissection
Cardiovascular Health Improvement Project
The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Bicuspid Aortic Valve (BAV), Heart Failure
- Trial name
- CHIP (NCT02306200)
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Bicuspid Aortic Valve
Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
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.
- Trial name
- NCT03836521
- Testing
- Transcatheter aortic valve replacement
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Cedars-Sinai Medical Center
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.