Clinical trials: Stenosis, Aortic
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.
Aortic Valve Stenosis
Morbidity and Mortality Due to Deferral of Aortic Valve Replacement in Patients With Severe Aortic Stenosis
Background and Project Rationale: Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or older and progresses insidiously with advancing age [1] before manifesting with symptoms such as decreased…
- Trial name
- AS DEFER (NCT04333875)
- Testing
- TAVR or SAVR
- Where
- Switzerland
- Volunteers
- 71 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice
This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.
- Trial name
- IRIS AVR (NCT03453567)
- Testing
- Valve Replacement
- Where
- 3 sites in South Korea
- Volunteers
- 900 people
- Sponsor
- Seung-Jung Park
Diastolic Heart Failure NYHA Class III-IV, Diastolic Dysfunction Secondary to Aortic Stenosis
CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction
The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".
- Trial name
- NCT01956526
- Testing
- CORolla™ TAA device
- Where
- 2 sites in Italy
- Volunteers
- 12 people
- Sponsor
- CorAssist Cadiovascular Ltd.
Aortic Valve Stenosis, Aortic Valve Calcification
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s).
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Mitral Annular Calcification, Mitral Valve Calcification
- Trial name
- NCT04429035
- Testing
- Vitamin K2
- Where
- 2 sites in Greece
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National and Kapodistrian University of Athens
Aortic Stenosis
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.
Study design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by…
- Trial name
- NCT05886517
- Testing
- Transfemoral transcatheter aortic valve implementation
- Where
- 4 sites in Italy, Spain
- Volunteers
- 200 people
- Sponsor
- AUSL Romagna Rimini
Aortic Valve Stenosis
Evaluation of an Intervention to Reduce the Time to Treatment for TAVI Patients
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population.
- Trial name
- TREAT (NCT05237804)
- Testing
- Patient component, Organisational component
- Where
- 2 sites in France
- Volunteers
- 828 people
- Sponsor
- University Hospital, Rouen
Hypertrophic Cardiomyopathy (HCM)
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- REDWOOD-HCM (NCT04219826)
- Testing
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg)
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 96 people
- Sponsor
- Cytokinetics
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