Clinical trials: Aortic Valve Stenosis
Aortic Stenosis, Severe
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers…
- Trial name
- TRACS (NCT05751577)
- Testing
- TAVI WITHOUT ON-SITE SURGERY, TAVI WITH ON-SITE SURGERY
- Where
- 14 sites in Italy
- Volunteers
- 657 people
- Sponsor
- Azienda Usl di Bologna
Aortic Valve Stenosis
Remote Ischemic Preconditioning in Aortic Valve Surgery
RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery.
- Trial name
- RIP-Valve (NCT01390129)
- Testing
- Control, Remote ischemic preconditioning
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Angers
Aortic Valve Stenosis
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe…
- Trial name
- NCT02701283
- Testing
- Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
- Where
- 87 sites in United States, Australia and 5 more
- Volunteers
- 2,223 people
- Sponsor
- Medtronic Cardiovascular
Amyloidosis, Aortic Valve Stenosis
Screening for Amyloidosis Before Aortic Valve Elective Replacement
Previous studies detected that up to 15% of patients undergoing aortic valve replacement (AVR) for degenerative aortic stenosis have concomitant transthyretin amyloidosis (ATTR) cardiomyopathy (Castano, 2017).
- Trial name
- SAVER (NCT04869631)
- Testing
- The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- Charite University, Berlin, Germany
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Aortic Valve Stenosis
TAVI in LOW RISK in the REAL WORLD
The primary objective is to assess all-cause mortality, the occurrence of stroke, or rehospitalization for cardiovascular causes in low-risk "all-comers" patients following percutaneous aortic valve replacement
- Trial name
- TAVI IN LOW R (NCT07605780)
- Where
- Italy
- Volunteers
- 650 people
- Sponsor
- Centro Cardiologico Monzino
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
HEParin Antagonisation in Transcatheter Aortic Valve Implantation
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Protamine Sulfate Overdose
- Trial name
- HepaTAVI (NCT05422170)
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Severe Aortic Valve Stenosis, Moderate Aortic Valve Stenosis
Future Optimal Research and Care Evaluation - Aortic Stenosis
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients.
- Trial name
- FORCE-AoS (NCT06168123)
- Testing
- Quality of life questionnaires will be assessed in addition to standard care
- Where
- Netherlands
- Volunteers
- 800 people
- Sponsor
- St. Antonius Hospital
Aortic Valve Stenosis, Aortic Valve Insufficiency
Enable® Aortic Sutureless Bioprosthesis Evaluation
The EASE Enable study is intended to collect additional data on the clinical outcomes of the Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
- Trial name
- EASE (NCT01720342)
- Testing
- Aortic Valve Replacement surgery
- Where
- 17 sites in France, Germany and 5 more
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Valve Disease, Mitral Valve (MV) Regurgitation
Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease
The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging…
- Conditions
- Heart Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis
- Trial name
- VALVE-COMPASS (NCT07267117)
- Where
- 15 sites in China
- Volunteers
- 10,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Postoperative Delirium, Aortic Valve Stenosis
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care…
- Trial name
- IPOD-AV (NCT03950440)
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Large Artery Stiffness, Aortic Disease
Phenotyping Heterogeneity and Regionality of the Aorta
The aorta distributes cardiac stroke volume into the whole body through its finetuned conductance function, that is propagation and modulation of flow pattern.
- Conditions
- Large Artery Stiffness, Aortic Disease, Aortic Stenosis, Aortic Aneurysm
- Trial name
- PHaRAo (NCT05603520)
- Testing
- Collection of Clinical Data
- Where
- Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Heinrich-Heine University, Duesseldorf
Aortic Valve Stenosis
Hydra Registry - Italy Experience
Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.
- Trial name
- NCT05956652
- Testing
- Hydra Transcatheter Aortic Valve System
- Where
- 4 sites in Italy
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Artery Disease, Coronary Arteriosclerosis
Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study
This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a…
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Atrial Fibrillation, Left Atrial Abnormality
- Trial name
- EPICHEART (NCT03280433)
- Testing
- Aortic valve replacement
- Where
- 2 sites in Portugal
- Volunteers
- 500 people
- Sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Heart Valve Diseases, Aortic Valve Stenosis
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- NCT07068633
- Where
- 2 sites in South Korea
- Volunteers
- 30,000 people
- Sponsor
- Yonsei University
Aortic Valve Stenosis
Rehabilitation in Aortic Stenosis Patients
SURVEY OF THE FIELD Aortic stenosis (AS) is the most common valve disease and increasing due to a growing elderly population. The therapy is aortic valve replacement (AVR).
- Trial name
- RASP (NCT01504737)
- Testing
- Aerobic Exercise Training, Physical Activity Recommendations
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- Linkoeping University
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Severe
Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden
The aim of the study is to evaluate the effect of antifibrotic therapy on regression of myocardial fibrosis after TAVI in patients with baseline high fibrotic burden.
- Trial name
- Reduce-MFA (NCT05230901)
- Testing
- Standard of Care, Spironolactone 25mg, Dihydralazine
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Medical Center Goettingen
Hypertrophic Cardiomyopathy
A Trial of HS-10511 in Healthy Subjects
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single…
- Trial name
- NCT06210607
- Testing
- HS-10511 Tablets
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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