A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
Aortic Valve StenosisThe purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients. Following initial implantation, all patients will have clinical follow up at 30 days, 3, months, 6 months and 12 months
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk...
Aortic StenosisTo 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.
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis...
Aortic Valve StenosisThis study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific,...
Aortic Valve StenosisThis 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 surgical aortic valve replacement (SAVR).
Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Intermediate...
Aortic Valve StenosisRandomized controlled, multi-center trial randomizing patients with symptomatic severe aortic stenosis at low to intermediate operative risk of mortality in a 1:1 fashion to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) to test, whether TAVI is non-inferior to SAVR, as measured by all-cause mortality or stroke after 1 and 5 years.
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve...
Aortic Valve StenosisAim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing...
Aortic StenosisAscending Aortic DilatationThis study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
Aortic Valve StenosisThis is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Symptomatic Aortic StenosisAortic Valve Stenosis1 moreThe purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.
Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR
Aortic StenosisTEAM-Br is a randomized, prospective, cost-utility study comparing transcatheter aortic valve implantation (TAVI) versus surgical aortic vale replacement in Brazil. The study is sponsored by the national Minister of Health, through PROADI-SUS (Programa de Apoio ao Desenvolvimento Institucional do SUS).