Evaluation of Effectiveness and Safety of Evolut R Valve In Patients With Pure Aortic Regurgitation...
Aortic ValveAortic Valve Insufficiency4 moreThis study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).
Perceval S Aortic Heart Valve Study- North America
Aortic Valve StenosisAortic Valve Stenosis With Insufficiency3 moreTo demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
Mitroflow DL Post Approval Study- North America
Aortic StenosisAortic Regurgitation8 moreProspective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
The CardioPAT Project: A Randomized Trial
Coronary Artery DiseaseAortic Stenosis3 moreThe purpose of this study is to determine whether intra- and postoperative use of the cardioPAT® cell saver decreases the need for allogenic red blood cell transfusion in patients, who undergo open heart surgery (with cardiopulmonary bypass) and preoperatively have an increased risk for bleeding.
Edwards SAPIEN-3 Periprosthetic Leakage Evaluation Versus Medtronic CoreValve in Transfemoral Aortic...
Periprosthetic Aortic Valve Regurgitation After TAVITranscatheter aortic valve replacement (TAVR) is a good alternative treatment for patients with severe aortic valve stenosis with similar mid-term success rates as compared to surgery. Periprosthetic aortic regurgitation (PAR) after TAVR remains an important limitation of this technique. Moderate to severe PAR occurs in 15-45% of the cases and it is an independent predictor of mortality after TAVR. Little is known about potential differences in severity of PAR among different types of aortic valve prosthesis. The current randomized study aims to evaluate potential differences between the Edwards SAPIEN bioprosthesis and the Medtronic CoreValve® system with main focus on PAR and additional focus on other clinical and imaging endpoints. Primary objective of this study is to investigate the difference in the severity of PAR, measured with 3-dimensional transesophageal echocardiography (3DTEE), between patients undergoing the implantation of the Edwards SAPIEN bioprosthesis versus patients receiving the Medtronic CoreValve® bioprosthesis. Secondary objectives of this study include: investigating the value of different imaging modalities in evaluating periprosthetic regurgitation after TAVR and studying the difference in clinical endpoints according to VARC-2 definitions and quality of life after TAVR between two available aortic valve prostheses.
Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients...
Aortic StenosisAortic Regurgitation3 moreTo compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
HAART 200 Aortic Valve Annuloplasty Trial
Aortic InsufficiencyThe HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Aortic Valve DisorderAortic Valve Insufficiency3 moreThe purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
Effect of Beta Blockade on Left Ventricular Remodeling and Function in Moderate to Severe Asymptomatic...
Aortic Valve InsufficiencyThe primary objective of this study is to evaluate the effect of beta-blocker on left ventricular (LV) remodeling in asymptomatic patients with moderate to severe aortic regurgitation.
HAART Model 300 Annuloplasty Ring
Aortic RegurgitationThis investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame