Clinical trials: Aortic Valve Calcification
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 VALVE DISEASES, Calcification; Heart
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
This is a prospective study that aims to develop clinical calculators that will report on the underlying rate of aortic valve calcification.
- Trial name
- NCT07819344
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
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
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 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
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 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.
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
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 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
Aortic Stenosis, Calcific
PCSK9 Inhibitors in the Treatment of Calcific Aortic Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- PICASO (NCT07256197)
- Testing
- Treatment with PCSK9 inhibitors, Treatment without PCSK9 inhibitors
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
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
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
Aortic Regurgitation Disease, Aortic Valve Calcification
Valvular Assessment of New Generation Aortic Replacement Devices
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement…
- Conditions
- Aortic Regurgitation Disease, Aortic Valve Calcification, Bicuspid Aortic Valve Disease
- Trial name
- VANGUARD (NCT06688448)
- Testing
- Dafodil prosthesis, Aortic Valve Replacement - Inspires Resilia prosthesis
- Where
- Brazil
- Volunteers
- 200 people
- Sponsor
- Instituto Dante Pazzanese de Cardiologia
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
Aortic Stenosis
Effect of PCSK9 Inhibitors on Calcific Aortic Valve Stenosis
Calcific aortic stenosis (CAS) can cause severe adverse cardiac events, but there are currently no effective drugs that can prevent or delay the progression of the disease.
- Trial name
- NCT04968509
- Testing
- PCSK9 inhibitors and statins with or without ezetimibe, Statins with or without ezetimibe
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Beijing Anzhen Hospital
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
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