Clinical trials: Calcification
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
Vascular Calcification, Hemodialysis
Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Disease Undergoing Hemodialysis
The goal of this clinical trial is to find out if using a citrate-based dialysate with added magnesium during hemodialysis can help slow down or prevent the hardening of blood vessels (vascular calcification) in adults on…
- Conditions
- Vascular Calcification, Hemodialysis, Cardiovascular Disease (CKD)
- Trial name
- CalCio-HD (NCT07163936)
- Testing
- Citrate dialysate with magensium supplementation, Acetate dialysate
- Volunteers
- 80 people
- Sponsor
- Hospital Clinic of Barcelona
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
Chronic Kidney Disease, Coronary Arteries Calcifications
CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality.
- Conditions
- Chronic Kidney Disease, Coronary Arteries Calcifications, CXCR2 Expression
- Trial name
- MACXCALCIF (NCT07811505)
- Testing
- Thoracic CT, Blood samples
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Coronary Artery Calcification, Cardiovascular Risk
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
This retrospective, non-interventional study externally validates a pre-trained open-weight deep-learning algorithm (Swin-UNETR) for the opportunistic quantification of coronary artery calcium (CAC) on non-gated routine chest CT…
- Conditions
- Coronary Artery Calcification, Cardiovascular Risk, Coronary Artery Disease, End-Stage Renal Disease Requiring Haemodialysis
- Trial name
- NCT07808593
- Volunteers
- 1,950 people
- Sponsor
- University of Cologne
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
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
Calciphylaxis
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic…
- Trial name
- SEAPORT 1 (NCT06283589)
- Testing
- INZ-701
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Inozyme Pharma
Myocardial Infarction (MI), Radiation Toxicity
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a…
- Conditions
- Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis, Coronary Thrombosis
- Trial name
- MARAA (NCT06565793)
- Testing
- Non Complex PCI, Complex PCI
- Where
- France
- Volunteers
- 15,630 people
- Sponsor
- Centre Cardiologique du Nord
Femoral Arterial Calcification, Peripheral Arterial Disease
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of…
- Conditions
- Femoral Arterial Calcification, Peripheral Arterial Disease, Claudication, Critical Limb Ischemia
- Trial name
- NCT05145478
- Testing
- Shockwave Intravascular Lithotripsy (IVL)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Calcification of Coronary Artery
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05447585
- Testing
- Coronary atherectomy system of Shanghai MicroPort Rhythm, Rotablator Rotational Atherectomy System
- Where
- China
- Volunteers
- 239 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
Coronary Artery Calcification
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05818098
- Testing
- Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
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
Coronary Artery Calcifications, Intravascular Lithotripsy
Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes…
- Conditions
- Coronary Artery Calcifications, Intravascular Lithotripsy, Rotational Atherectomy, Intravascular Ultrasound
- Trial name
- LIRAC (NCT07750964)
- Testing
- intravascular lithotripsy, rotational atherectomy
- Volunteers
- 190 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency
Natural History Study: ENPP1 Deficiency or the Early-Onset Form of ABCC6 Deficiency
The purpose of this study is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) Deficiency and the early-onset form of adenosine triphosphate binding cassette transporter subfamily C…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency, Generalized Arterial Calcification of Infancy, Autosomal Recessive Hypophosphatemic Rickets
- Trial name
- NCT07745179
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 23 people
- Sponsor
- Inozyme Pharma
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral…
- Trial name
- SKYWARD TF (NCT07512128)
- Testing
- Carotid Intravascular Lithotripsy
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Generalized Arterial Calcification of Infancy, Autosomal Recessive Hypophosphatemic Rickets Type2
Study of People With Generalized Arterial Calcification of Infancy (GACI) or Autosomal Recessive Hypophosphatemic Rickets Type 2 (ARHR2)
Background: Generalized Arterial Calcification of Infancy (GACI) is a very rare disorder. It can be fatal before birth or by age 6 months. Anumber of people with GACI survive into adulthood.
- Trial name
- NCT03478839
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
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.
Breast Cancer, Cardiovascular (CV) Risk
Multicenter Cardiac Decision Impact Study in People With Breast Cancer
Background: Breast cancer is the most common cancer in women, and advances in early detection and treatment have led to steadily improved survival rates. Today, nearly 80% of breast cancer survivors are over 50 years of age.
- Conditions
- Breast Cancer, Cardiovascular (CV) Risk, Coronary Artery Calcifications
- Trial name
- CarDI (NCT07703033)
- Testing
- Measuring coronary artery calcifications (Agatston score) using routine radiotherapy planning CT scans and communicating the associated risk of cardiovascular disease to the patient.
- Where
- 5 sites in Denmark, Germany and 2 more
- Volunteers
- 1,000 people
- Sponsor
- UMC Utrecht