SLOW-Slower Progress of caLcificatiOn With Vitamin K2
Aortic Valve StenosisAortic Valve Calcification3 moreA 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). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age < 50 y.o,prosthetic valves,Aortic Valve area (AVA) < 1cm2 ,Vmax > 4 m/s
RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH...
Aortic Valve StenosisOpen-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery:...
Aortic StenosisStudy design: single arm, interventional and multicenter study. The objectives are evaluate Safety and efficacy of TAVI in Department of Cardiology without on site cardiac Surgery for symptomatic severe aortic valve stenosis by expert operator team, in patients with prohibitive surgical risk. For the pilot phase, 20 patients will be enrolled. For whole study, all consecutive patients undergoing TAVI in center without CS on site will be enrolled to reach a number of about 200 patients.
Clinical Trial in China for Aortic Valve Stenosis
Diseases of Aortic ValveAortic Stenosis DiseaseThe purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
Comparison of Different Vascular Closure Device in TAVI
Aortic Valve StenosisTranscatheter Aortic Valve ImplantationFemoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
Aortic StenosisSevereThe objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Anxiety Reduction in TAVI Using Virtual Reality Trial
Aortic StenosisSevere1 moreThe ART-VR Trial is an international multi-center, open label, randomized controlled trial evaluating the effect of an immersive VR environment on procedural anxiety in patients undergoing transfemoral aortic valve replacement (TAVR) under local anaesthesia.
Portico and Navitor India Clinical Trial
Aortic Valve StenosisAortic Valve Failure2 moreThe objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.
Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic...
Aortic StenosisThe primary purpose of the LAA-CLOSURE trial is to assess the efficacy and safety of surgical closure of LAA in patients undergoing aortic valve replacement. This randomized, prospective, open-label international multicenter trial will enroll 1040 patients undergoing aortic valve replacement with CHA2DS2-VASC score ≥2 but without an indication for anticoagulation at the time of enrollment. Patients will be randomized in 1:1 fashion to standard therapy + surgical closure of LAA vs. standard therapy alone. The duration of the study is five years (plus additional 10 years).
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
Symptomatic Aortic StenosisThe purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.