Clinical trials: Aortic Valve Disease
Aortic Valve Stenosis
REST Study: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance…
- Trial name
- NCT00256165
- Testing
- Tissue valve
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Aortic Valve Disease
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
- Trial name
- NCT05295628
- Testing
- EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
- Where
- 23 sites in United States
- Volunteers
- 532 people
- Sponsor
- Emblok, Inc.
Aortic Valve Stenosis, Heart Valve Diseases
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
- Trial name
- ENVISION (NCT05932615)
- Testing
- Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Insufficiency
Results of the Aortic Valve Reconstruction in Children
Aortic valve disease counts up to 5% of cases of congenital heart disease being one of the most common congenital malformations of the cardiovascular system.
- Trial name
- NCT04162444
- Testing
- Physical examination, The Ross Classification for Heart Failure in Children, The Aristotle score
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- National Medical Research Center for Children's Health, Russian Federation
Stenoses, Aortic
SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients
Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by…
- Trial name
- SAFARI (NCT05983458)
- Testing
- Transaortic valve replacement
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Maria Cecilia Hospital
Coronary Artery Disease, Heart Failure
Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging
With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD.
- Conditions
- Coronary Artery Disease, Heart Failure, Hypertrophic Cardiomyopathy, Congenital Heart Disease
- Trial name
- SE2030 (NCT05081115)
- Testing
- ABCDE-Stress Echo, SE diastolic assessment, SE Right ventricular function assessment
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- Fatebenefratelli Hospital
Aortic Valve Stenosis
Microparticles in Severe Aortic Stenosis
Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic…
- Trial name
- NCT02193035
- Testing
- Microparticle levels
- Where
- Brazil
- Volunteers
- 15 people
- Sponsor
- InCor Heart Institute
Hypertrophic Cardiomyopathy
Family Studies of Inherited Heart Disease
Hypertrophic cardiomyopathy (HCM) is a genetically inherited heart disease. It causes thickening of heart muscle, especially the chamber responsible for pumping blood out of the heart, the left ventricle.
- Trial name
- NCT00001225
- Where
- United States
- Volunteers
- 5,880 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypertrophic Cardiomyopathy (HCM), Obstructive Hypertrophic Cardiomyopathy (oHCM)
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
This retrospective cohort study aims to evaluate the clinical efficacy and safety of mavacamten in adult patients with obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- MAVA-HCM (NCT07529938)
- Testing
- mavacamten
- Where
- China
- Volunteers
- 222 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Aortic Stenosis, Gastrointestinal Microbiome
Involvement of the Gut Microbiota in Calcified Aortic Stenosis
Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation.
- Conditions
- Aortic Stenosis, Gastrointestinal Microbiome, Metabolomics
- Trial name
- Gut-CAS (NCT06021535)
- Testing
- No intervention
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cardiovascular Diseases, Aortic Valve Stenosis
Translational-Omics in Aortic Stenosis (TOmAS) Biobank
The objective of the TOmAS Biobank is the conservation of biological material (plasma, saliva, and tissue explanted during surgery), genetic material (DNA, RNA, etc.), and clinical data ("material/data") collected from patients…
- Trial name
- NCT05930899
- Testing
- Genetics
- Where
- 2 sites in Canada
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Valvular Heart Disease
The Bronx-Valve Registry
The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams.
- Trial name
- NCT05453526
- Where
- United States
- Volunteers
- 330,570 people
- Sponsor
- Montefiore Medical Center
Aortic Valve Disease, Aortic Valve Stenosis
Myeloid Cells in Aortic Valve Stenosis
Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.
- Trial name
- MIRACLE (NCT04717219)
- Testing
- Blood drawing
- Where
- 3 sites in Netherlands
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Severe Aortic Valve Stenosis
A Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis
This study will include patients with severe degenerative aortic stenosis (AS) who meet the inclusion criteria and voluntarily participate (planned to undergo TAVI), as well as patients with aortic stenosis who have not undergone…
- Trial name
- NCT07335900
- Testing
- Transcatheter Aortic Valve Implantation, Optimal medication treatment
- Where
- China
- Volunteers
- 25 people
- Sponsor
- RenJi Hospital
Transcatheter Aortic Valve Implantation, Acute Kidney Injury
Effectiveness of the NephroCheck™ After TAVI
Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI) early enough to prevent an organic dysfunction…
- Conditions
- Transcatheter Aortic Valve Implantation, Acute Kidney Injury, Postoperative Acute Renal Failure
- Trial name
- AKI-TAVI (NCT02976792)
- Testing
- Renal Resistive Index/NephroCheck™test
- Where
- France
- Volunteers
- 62 people
- Sponsor
- University Hospital, Bordeaux
Aortic Valve Stenosis, Mitral Regurgitation
Phono- and Electrocardiogram Assisted Detection of Valvular Disease
The diagnosis of valvular heart disease (VHD), or its absence, invariably requires cardiac imaging. A familiar and inexpensive tool to assist in the diagnosis or exclusion of significant VHD could both expedite access to…
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Heart Murmurs, Valvular Heart Disease
- Trial name
- PEA-Valve (NCT03458806)
- Testing
- AS Algorithm 1, AS Algorithm 2, MR Algorithm 1
- Where
- United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Aortic Valve Disease
Twenty-five-year Experience With the Medtronic-Hall Valve Prosthesis
Background-:. The Medtronic-Hall (MH) valve was developed and for the first time implanted in Oslo in 1977. A total of 1,104 patients received this valve at Rikshospitalet-Radiumhospitalet HF in the period 1977-87.
- Trial name
- Hall-Kaster (NCT00486928)
- Where
- Norway
- Volunteers
- 816 people
- Sponsor
- Oslo University Hospital
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
Conduction Disturbance, Trans Aortic Valve Implantation (TAVI)
Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and…
- Trial name
- STIM TAVI MS (NCT04906837)
- Testing
- Trans aortic valve implantation
- Where
- France
- Volunteers
- 197 people
- Sponsor
- Association de Recherche en Cardiologie des Alpes
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