Clinical trials: Calcified Aortic Valve Disease
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Valve Heart Disease
Freestyle-Perimount Calcification Comparison
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount…
- Trial name
- NCT04359030
- Testing
- Multislice CT scanning for aortic wall calcification, Transthoracic stress echocardiography
- Where
- Belgium
- Volunteers
- 90 people
- Sponsor
- Ziekenhuis Oost-Limburg
Aortic Valve Stenosis
A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis.
- Trial name
- CAVS (NCT02481258)
- Testing
- Ataciguat (HMR1766)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
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, Aortic Sclerosis
Risk Factors Associated With Calcification of the Aortic Valve
The purpose of this study is to determine the degree of endothelial dysfunction and inflammation in calcific aortic valve disease associated with coronary artery disease(CAD).
- Trial name
- NCT00375336
- Where
- Czechia
- Volunteers
- 300 people
- Sponsor
- Charles University, Czech Republic
Aortic Stenosis
Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry
The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- SAINT-TAVR Ca (NCT06722066)
- Testing
- Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Eunpyeong St. Mary's Hospital
Coronary Artery Disease, Aortic Valve Disease
Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
The goal of the 3D-CARDIOPATH study is to investigate the potential added value of emerging 3D imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials)…
- Conditions
- Coronary Artery Disease, Aortic Valve Disease, Aortic Valve Calcification, STEMI
- Trial name
- 3D-CARDIOPATH (NCT05975567)
- Testing
- Three-dimensional imaging of the collected cardiac specimens
- Volunteers
- 70 people
- Sponsor
- Aristotle University Of Thessaloniki
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 Disease, Aortic Valve Stenosis
Myeloid Cells in Aortic Valve Stenosis
Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.
- Trial name
- MIRACLE (NCT04717219)
- Testing
- Blood drawing
- Where
- 3 sites in Netherlands
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Radboud University 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"
Hypertension, Aortic Stenosis, Calcific
Pressure Assessment to Improve Outcomes After TAVR: a Registry
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures.
- Conditions
- Hypertension, Aortic Stenosis, Calcific, Quality of Life, Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT03923530
- Testing
- Eplerenone
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- North Florida Foundation for Research and Education
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
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 Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation
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
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
Calcific Aortic Valve Disease, Aortic Valve Stenosis
Serum and Cellular Biomarkers for Aortic Valve Stenosis
AthenaValve aims to develop and initial validate a novel serum diagnostic kit, for the assessment of severity and prognosis of progression of aortic valve stenosis (AS, a devastating disease without early diagnosis and medical…
- Conditions
- Calcific Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of
- Trial name
- AthenaValve (NCT04312139)
- Testing
- Echocardiography, Computerized Tomography Aortic Valve Calcium Score, Untargeted LC/MS and LC-MS/MS
- Where
- 2 sites in Greece
- Volunteers
- 280 people
- Sponsor
- National and Kapodistrian University of Athens
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.
Heart Disease
4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure.
- Trial name
- C4CAPRI (NCT02935491)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- France
- Volunteers
- 1,600 people
- Sponsor
- Hospices Civils de Lyon
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- 2 sites in United States, Australia
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health