ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral...
Aortic StenosisClinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
EDWARDS INTUITY Valve System CADENCE-MIS Study
Aortic Valve DiseaseAortic StenosisThe study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
CardioCel Tri-leaflet Repair Study
Aortic StenosisAortic InsufficiencyThis study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.
Heart FailureDiastolic4 moreThe investigators want to compare the effects of two drugs, levosimendan and milrinone, on cardiac muscle, both in terms of contractility and relaxation. Half of the participants will be randomized to each drug. The effects will be measured through echocardiographic deformation analyses. Since deformation analyses could be dependent on different loading conditions of the heart, a second purpose of the study is to investigate the changes on deformation parameters after applied changes in preload and afterload, but also heart rate.
Severe Aortic Stenosis and Acquired Von Willebrand´s Disease: The Impact of Desmopressin in Valve-Replacement...
Acquired Von Willebrand Disease Secondary to Severe Aortic StenosisHeye´s Syndrome1 moreAcquired Von Willebrand disease (type 2A) has been described in patients with severe aortic stenosis, the association of aortic stenosis and Digestive bleeding due to this phenomena has received the name of Heye´s syndrome. We propose that administering Desmopressin (DDAVP) in patients scheduled to aortic valve replacement surgery will reduce blood loss and transfusion rate. this was a pilot study
DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device...
Aortic Valve StenosisA randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.
Coronary and Structural Interventions - Transcatheter Aortic Valve Replacement
Aortic Valve StenosisTo evaluate the long-term results after transcatheter aortic valve replacement
Engager Direct Aortic Clinical Study
Aortic Valve StenosisTo confirm the safety and performance of the Medtronic Engager™ Transcatheter Aortic Valve Implantation System via direct aortic approach.
Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement...
Aortic StenosisThe purpose of this study is to investigate if methylprednisolone is effective in reducing the cerebral inflammatory response after open heart surgery with cardiopulmonary bypass.
Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis
Symptomatic Aortic StenosisEligible for Transcatheter Aortic Valve ReplacementATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who have undergone a successful TAVI procedure. The randomization is stratified according to the presence or not of a mandatory indication for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or DVT/PE).