Clinical trials: Calcified Aortic Valve Disease
Aortic Stenosis, Calcific
Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism…
- Trial name
- FIB-AS (NCT03585933)
- Testing
- Cardiac magnetic resonance imaging
- Where
- 2 sites in Denmark, Lithuania
- Volunteers
- 110 people
- Sponsor
- Vilnius University
Aortic Valve Stenosis, Aortic Valve Insufficiency
Clinical Investigation for the Foldax Tria Aortic Heart Valve- India
The purpose of this study is to conduct a clinical investigation of the Foldax Tria Aortic Valve to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- NCT06192706
- Testing
- Foldax Tria Aortic Valve
- Where
- 10 sites in India
- Volunteers
- 50 people
- Sponsor
- Foldax, Inc
Aortic Stenosis, Calcific, Aortic Valve Stenosis
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.
- Trial name
- PROGRESS (NCT04889872)
- Testing
- SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,250 people
- Sponsor
- Edwards Lifesciences
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
Vascular Calcification, Chronic Kidney Diseases
a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.
- Trial name
- NCT03858413
- Testing
- No intervention
- Volunteers
- 60 people
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
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
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 Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Calcific Aortic Valve Disease
Exploration of Manidipine to Reverse Aortic Valve Calcification
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of manidipine compared to placebo in patients with calcific aortic valve disease with…
- Trial name
- NCT07091136
- Testing
- manidipine
- Volunteers
- 100 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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, Multidetector Computed Tomography
The Aortic Valve DECalcification (AVADEC) Trial
Aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. The disease is progressive with increasing calcification of the valve cusps.
- Conditions
- Aortic Valve Stenosis, Multidetector Computed Tomography, Vitamin K 2, Randomised Clinical Trial
- Trial name
- AVADEC (NCT03243890)
- Testing
- Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).
- Where
- Denmark
- Volunteers
- 389 people
- Sponsor
- Axel Diederichsen
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
Colchicine and Inflammation in Aortic Stenosis
Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation
- Trial name
- CHIANTI (NCT05162742)
- Testing
- Colchicine
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Radboud University Medical Center
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body.
- Conditions
- Calcific Aortic Valve Disease, AORTIC VALVE DISEASES, Aortic Valve Stenosis
- Trial name
- VERIFICATION (NCT07715279)
- Testing
- Vericiguat (BAY1021189)
- Where
- China
- Volunteers
- 238 people
- Sponsor
- West China Hospital
Calcific Aortic Valve Diasease
Calcific Aortic Valve Disease:the Role of Bacteria as Trigger of a Chronic Inflammation
Calcific aoric valve disease (CAVD) is extremely common worldwide, affecting almost 50% of the population over 85 years of age, with a lethality higher than 50% at 2 years for symptomatic patients, unless aortic-valve replacement…
- Trial name
- NCT05806411
- Testing
- Analysis of calcific aortic valves
- Where
- Italy
- Volunteers
- 44 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Aortic Stenosis, Symptomatic Aortic Stenosis
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- DurAVR™ EFS (NCT05712161)
- Testing
- DurAVRTM THV System
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
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
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