Clinical trials: Heart 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.
Osteoblast, Vascular Calcification
Use of Discarded Surgery Human Tissue Specimens for Basic Science Research
Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events.
- Trial name
- HumTisRes (NCT04753593)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Mitral Annulus Calcification, Rheumatic Heart Disease
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral stenosis (MS) is a heavily symptomatic valvular heart disease. Common causes of MS included chronic rheumatic heart disease (CRHD) and mitral annular calcification (MAC).
- Trial name
- SMARTMAC (NCT06952374)
- Testing
- SmartWave Lithotripsy balloon
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Mitral Regurgitation, Mitral Valve Disease
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry
This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR).
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Annular Calcification
- Trial name
- CHOICE-MI (NCT04688190)
- Where
- 43 sites in United States, Australia and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
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
Aortic Stenosis, PCSK9 Inhibitor
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease
The aim of this clinical trial is to understand whether the drug PCSK9 inhibitor can slow the progression of calcific aortic valve disease and to understand the safety of the drug.
- Conditions
- Aortic Stenosis, PCSK9 Inhibitor, Calcified Aortic Valve Disease
- Trial name
- NCT06996223
- Testing
- The Group A received PCSK9 inhibitor plus statin therapy
- Volunteers
- 316 people
- Sponsor
- Nanfang Hospital, Southern Medical University
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
Iliac Disease, Aortic Valve Stenosis
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
To assess the efficacy and safety of Intravascular Lithotripsy (IVL) in subjects undergoing transfemoral TAVR in patients with severe iliac disease, prohibitive for transfemoral TAVR in patients with severe symptomatic aortic…
- Trial name
- ILIT (NCT05862558)
- Testing
- Shockwave Balloon
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Baylor Research Institute
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, 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 Valve Stenosis
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
The purpose of this study is to investigate whether mutations in genes coding for Na/Pi-cotransporters are associated with aortic valve calcification.
- Trial name
- NCT01939678
- Where
- Sweden
- Volunteers
- 3 people
- Sponsor
- Region Örebro County
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Calcification, Aortic Stenosis
Prevalence and Significance of Mutations in Genes Encoding NaPi-co-transporters in the Development of CAVD
Mutations in the SLC34A2 gene, that encodes the sodium phosphate co-transporter (NaPi-IIb), cause defect cell-uptake of phosphate, which leads to formation of calcium-phosphate concretions in the lungs as seen in Pulmonary…
- Trial name
- NCT02516800
- Where
- Denmark
- Volunteers
- 600 people
- Sponsor
- University of Aarhus
Aortic Valve Stenosis, AV Block
Edwards SAPIEN 3 PPI Registry
There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.
- Conditions
- Aortic Valve Stenosis, AV Block, Bundle-Branch Block
- Trial name
- Conduct (NCT03497611)
- Testing
- transcatheter valve implantation
- Where
- 4 sites in Germany
- Volunteers
- 1,000 people
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
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
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
Mitral Regurgitation, Mitral Stenosis
Abbott Cephea Mitral Valve Disease Registry
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease.
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation
- Trial name
- NCT07069673
- Where
- 24 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences