Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender...
Aortic Valve StenosisThe goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study. The main questions the study aims to answer are: Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system. Gender differences in LV remodelling associates with different levels of sexual hormones. Patients participating in the study will be asked to undergo: Cardiac ultrasound, MR- and CT-scan prior to surgery Blooddraw prior to surgery. Heartmuscle biopsy during surgery Cardiac MR-scan 1 year after surgery.
EDWARDS INTUITY Valve System CADENCE Study
Aortic Valve DiseaseAortic StenosisThe study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
Quality of Life After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement
Aortic Valve StenosisHeart Valve Diseases1 moreThis is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open...
Severe and Symptomatic Aortic StenosisStable Coronary DiseaseEvaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
Aortic Valve StenosisThe study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
Aortic Valve StenosisTo evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.
Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome
Aortic StenosisHypoplastic Left Heart SyndromeFor fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve fetal growth of left heart structures and thus improve potential for biventricular repair strategies after birth.
A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure...
Aortic Valve StenosisA pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and Closure Device for accessing and closing the left ventricular apex during and after Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made post-procedure, at 30 days and 90 days as well as longer term follow-up.
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic...
Aortic Valve StenosisThe primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.
Freedom SOLO Stentless Heart Valve Study
Aortic StenosisAortic InsufficiencyThe purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.