Clinical trials: Calcific Aortic Stenosis
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Calcification
Comparison of Aortic Root Dimension Changes During Cardiac Cycle Between the Patients With and Without Aortic Valve Calcification Using ECG-gated 64-slice and Dual-source 256-slice Computed Tomography Scanners: Results of a Multicenter Study
This study seeks to compare aortic dimension changes during cardiac cycle in patients with and without aortic valve calcification and to evaluate its correlation with aortic valve calcium score in former group.
- Trial name
- NCT01755806
- Where
- 3 sites in Iran
- Volunteers
- 104 people
- Sponsor
- Modarres Hospital
Aortic Valve Stenosis, Aortic Stenosis
Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve
Aortic stenosis is a commonly found heart disease, which often leads to mortality and morbidity. Valve replacement using mechanical prosthetic valve will have an expensive cost especially in the Integrated Heart Center of Cipto…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Valve Stenoses, Aortic, Aortic Valve Calcification
- Trial name
- NCT04056832
- Testing
- Single Strip Pericardium, Mechanical Prosthetic Valve
- Where
- Indonesia
- Volunteers
- 62 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Aortic Valve Calcification
Vitamin K Supplement for Inhibition of the Progress in Aortic Valve Calcification
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated.
- Trial name
- 08-002 (NCT00785109)
- Testing
- Vitamin K supplementation
- Where
- Germany
- Volunteers
- 99 people
- Sponsor
- RWTH Aachen University
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Iron Deficiencies, Calcified Aortic Valve
ID as a Promoter of IH-induced CAVD
Calcific aortic valve disease (CAVD) is a highly prevalent, disabling and costly disorder with generally poor long-time outcomes once critical stenosis presents with symptoms.
- Trial name
- NCT06200870
- Volunteers
- 3,000 people
- Sponsor
- Qilu Hospital of Shandong University
Calcification of Aortic Valve, Aortic Valve Stenosis
Effects of Pioglitazone in Calcific Aortic Valve Disease
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of pioglitazone compared to placebo in patients with calcific aortic valve disease…
- Trial name
- NCT05875675
- Testing
- Drug: Pioglitazone Oral Tablet
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Calcific Aortic Stenosis
Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.
Aortic stenosis is a condition whereby one of the heart valves (aortic valve) becomes narrowed, due to calcium deposition, over time. This can lead to chest pain, heart failure and sudden death.
- Trial name
- SALTIRE II (NCT02132026)
- Testing
- Denosumab, Alendronic Acid
- Where
- United Kingdom
- Volunteers
- 152 people
- Sponsor
- University of Edinburgh
Aortic Stenosis
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
- Trial name
- NCT05646381
- Testing
- Pelacarsen (TQJ230) 80mg
- Where
- 140 sites in United States, Austria and 13 more
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Stenosis, Chronic Coronary Syndrome
Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study
The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for…
- Conditions
- Aortic Stenosis, Chronic Coronary Syndrome, Calcific Aortic Valve Disease, Calcific Aortic Stenosis
- Trial name
- Echo-AVCS (NCT07620925)
- Testing
- Echocardiography and Cardiac CT
- Where
- 5 sites in Italy
- Volunteers
- 250 people
- Sponsor
- Azienda Ospedaliera "Sant'Andrea"
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Sclerosis, Aortic Valve Stenosis
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
Aortic stenosis is the most common valvular heart disease and an important public-health problem. Surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using…
- Conditions
- Aortic Valve Sclerosis, Aortic Valve Stenosis, Stenosis Progression, Valvular Heart Disease
- Trial name
- PASP (NCT02241109)
- Testing
- no intervention
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Aortic Valve Stenosis
The Effect of Lipitor on Aortic Stenosis
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic…
- Trial name
- NCT00590135
- Testing
- atorvastatin (Lipitor)
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Disease, Aortic Valve Stenosis
Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Prosthetic Valve Malfunction
- Trial name
- NCT04557345
- Testing
- Determination of cytokines, Two-dimensional transthoracic echocardiogram
- Where
- Mexico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Heart Valve Disease, Aortic Stenosis
Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications
Intervention study focused on preventing the progression of aortic valve calcification. Vascular and cardiac calcifications are a marker of risk and poor outcome, especially the severe calcified aortic stenosis and coronary…
- Trial name
- CALCIFICA (NCT01000233)
- Testing
- Phytine (phytate)
- Where
- Spain
- Volunteers
- 250 people
- Sponsor
- Hospital Universitari Son Dureta
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Stenosis, Imaging
Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study
Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the…
- Conditions
- Aortic Stenosis, Imaging, Pathogenesis, Disease Progression
- Trial name
- NCT05851209
- Where
- 3 sites in Germany
- Volunteers
- 938 people
- Sponsor
- Heinrich-Heine University, Duesseldorf