Clinical trials: AORTIC VALVE DISEASES
Cardiovascular Diseases, Heart Failure
Development of CIRC Technologies
Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization.
- Conditions
- Cardiovascular Diseases, Heart Failure, Ischemic Heart Disease, Non-ischemic Cardiomyopathy
- Trial name
- CIRC (NCT05654272)
- Testing
- MRI
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- The Cleveland Clinic
Williams Syndrome
Clemastine Treatment in Individuals With Williams Syndrome
This study explores the neurobiological etiology of Williams syndrome and potential therapeutic targets for associated social, motor, and cognitive abnormalities.
- Trial name
- NCT06087757
- Testing
- Open Label Clemastine with a blinded randomize withdrawal
- Where
- 2 sites in Israel
- Volunteers
- 30 people
- Sponsor
- Sheba Medical Center
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Real-World Effectiveness of Mavacamten in Canada
The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM)…
- Trial name
- MAVEN (NCT06338202)
- Testing
- Mavacamten
- Where
- Canada
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Severe Aortic Stenosis
Aspirin vs Clopidogrel After TAVR
Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive…
- Trial name
- NCT05493657
- Testing
- Aspirin single antiplatelet therapy, Clopidogrel single antiplatelet therapy
- Where
- South Korea
- Volunteers
- 270 people
- Sponsor
- Yonsei University
Hypertrophic Cardiomyopathy
VIZ ACCESS HCM - Multi-Site Registry
To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM.
- Trial name
- NCT07103057
- Testing
- Viz HCM
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Viz.ai, Inc.
Aortic Regurgitation Disease, Aortic Insufficiency
Impact of Anesthesia, Positive Pressure Ventilation and Modality of Imaging on the Echocardiographic Assessment of the Severity of Aortic Regurgitation
The goal of this observational study is to assess the impact of imaging modality (trans-thoracic echo (TTE) vs trans-esophageal echo (TEE)), anesthesia and positive pressure ventilation on the grading of aortic insufficiency.
- Trial name
- NCT06835946
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- University of Liege
Aortic Valve Stenosis, Limited Access Aortic Valve Replacement
Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement
The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS).
- Conditions
- Aortic Valve Stenosis, Limited Access Aortic Valve Replacement, Quality of Life
- Trial name
- LIAR (NCT04012060)
- Testing
- Limited access aortic valve replacement., Conventional aortic valve replacement
- Where
- Netherlands
- Volunteers
- 161 people
- Sponsor
- St. Antonius Hospital
Aortic Valve Stenosis, Heart Valve Diseases
First in Man Study of the JenaValve TAVI Plus System Transfemoral
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- CP-0001 (NCT02818959)
- Testing
- JenaValve Pericardial TAVR System
- Where
- 2 sites in Germany
- Volunteers
- 7 people
- Sponsor
- JenaValve Technology, Inc.
Hypertrophic Cardiomyopathy (HCM)
Multicentre Hypertrophic Cardiomyopathy Registry
Hypertrophic cardiomyopathy (HCM) is the most common inherited heart condition, affecting approximately 1 in 500 people. It causes the heart muscle to thicken, which can lead to blockages in blood flow (left ventricular outflow…
- Trial name
- NCT07381894
- Where
- United Kingdom
- Volunteers
- 2,500 people
- Sponsor
- University of Manchester
Glutathione Peroxidase Activity, Aortic Stenosis
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure.
- Conditions
- Glutathione Peroxidase Activity, Aortic Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- NCT04268160
- Testing
- Blood draw to measure GPx activity, Blood draw to measure SOD activity, Blood draw to measure Lp(a) levels
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
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
Hypertrophic Cardiomyopathy
Treatment of Preclinical Hypertrophic Cardiomyopathy With Diltiazem
This is a pilot clinical trial to assess whether the administration of diltiazem may be able to decrease the development or progression of hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT00319982
- Testing
- Diltiazem
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Brigham and Women's Hospital
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Aortic Valve Disease, Myocardial Infarction
Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI
The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic…
- Conditions
- Aortic Valve Disease, Myocardial Infarction, Stroke, Bleeding
- Trial name
- ARTE (NCT02640794)
- Testing
- Clopidogrel, Aspirin
- Where
- 4 sites in Canada, Chile and 1 more
- Volunteers
- 222 people
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Hypertrophic Cardiomyopathy, Endothelial Dysfunction
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies.
- Trial name
- HCM-Vein (NCT04129905)
- Testing
- BNP blood sample test, Electrocardiogram, Holter ECG
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Aortic Stenosis
Post-Market Clinical Follow Up Study With Navitor Valve
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
- Trial name
- VISTA Nova (NCT06008080)
- Testing
- Navitor Transcatheter Aortic Valve, FlexNav Delivery System, Navitor Loading System
- Where
- 50 sites in Australia, France and 9 more
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Hypertrophic Cardiomyopathy
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats.
- Trial name
- 3D-CMH (NCT03550573)
- Testing
- CardioInsight™ Noninvasive 3D Mapping System
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon