Clinical trials: Calcification; Heart
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 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
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
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD III With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic…
- Trial name
- NCT03595176
- Testing
- Lithotripsy
- Where
- 48 sites in United States, France and 2 more
- Volunteers
- 431 people
- Sponsor
- Shockwave Medical, Inc.
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
Mitral Valve Disease
Mitral Implantation of TRAnscatheter vaLves
The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular…
- Trial name
- MITRAL (NCT02370511)
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 15 sites in United States
- Volunteers
- 91 people
- Sponsor
- Mayra Guerrero
Coronary Artery Disease
Side Branch FFR After Provisional Stenting
The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT).
- Trial name
- ORBID-FFR (NCT03115580)
- Testing
- Rotational atherectomy, Cutting Balloon Angioplasty
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Coronary Artery Disease
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis
The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.
- Trial name
- NCT03169062
- Testing
- Gated Stationary Chest Tomosynthesis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of North Carolina, Chapel Hill
Type 1 Diabetes, Coronary Artery Calcification
Cardiovascular Risk Stratification in Young People With Type 1 Diabetes
The aim of the study is to compare ESC recommendations on cardiovascular (CV) risk stratification with the achievement of a CAC (Coronary Artery Calcification).
- Trial name
- CACD1 (NCT05283538)
- Testing
- Coronary Artery Calcification Realization
- Where
- France
- Volunteers
- 91 people
- Sponsor
- Poitiers University Hospital
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
- Trial name
- EMPOWER CAD (NCT05755711)
- Testing
- Shockwave Medical Coronary IVL System
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 399 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
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
Coronary Calcification
Warfarin and Coronary Calcification Project
The purpose of the study is to assess whether the use of warfarin, a commonly used anticoagulation drug, is associated with increased amounts of coronary artery calcification.
- Trial name
- WACC (NCT00868712)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Walter Reed Army Medical Center
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
Coronary Artery Disease, Atherosclerosis
Rotational Atherectomy Combined With Cutting Balloon to Optimize Stent Expansion in Calcified Lesions
Rotational atherectomy is an established tool to treat blocked arteries in the heart, in which the blockage is due to significant amounts of calcified material.
- Trial name
- ROTA-CUT (NCT04865588)
- Testing
- rotational atherectomy, cutting balloon, plain old balloon
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Samin Sharma, M.D., F.A.C.C., M.S.C.A.I.
Chronic Kidney Disease, Vitamin D Deficiency
Vitamin D and Coronary Calcification Study
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths.
- Conditions
- Chronic Kidney Disease, Vitamin D Deficiency, Coronary Calcification, Disorders of Calcium and Bone Metabolism
- Trial name
- VCOR (NCT00752102)
- Testing
- Calcitriol (Rocaltrol®), Paricalcitol
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Joslin Diabetes Center
Complication of Hemodialysis, Cardiovascular Diseases
Sodium Thiosulfate Treatment of Vascular Calcification in ESRD
Cardiovascular disease is the major cause of death in the hemodialysis population and calcification of the major arteries (coronary, aorta, and carotid) are a play a central role in this process.
- Trial name
- NCT00568399
- Testing
- sodium thiosulfate
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Washington University School of Medicine
Mitral Annular Calcification
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at…
- Trial name
- SITRAL (NCT02830204)
- Testing
- Mitral Valve Replacement (MVR) with Sapien3
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Baylor Research Institute
Cardiovascular Diseases, Cardiovascular Abnormalities
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
The primary objective is to assess the effect of 2 dose levels of SNF472 (300 mg and 600 mg) compared to placebo on the progression of coronary artery calcium volume score over a 12-month (52 weeks) period in ESRD patients on HD
- Conditions
- Cardiovascular Diseases, Cardiovascular Abnormalities, Calcifications, Vascular, Endstage Renal Disease
- Trial name
- NCT02966028
- Testing
- SNF472
- Where
- 75 sites in United States, Spain and 1 more
- Volunteers
- 274 people
- Sponsor
- Sanifit Therapeutics S. A.