Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Aortic Valve StenosisExpand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
Inflammatory Response to Aortic Valve Replacement
Aortic Valve StenosisA controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.
TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3
Aortic Valve StenosisBalloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.
PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves...
Aortic Valve StenosisA single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.
An Observational, Prospective Evaluation of the Trifecta™ Valve
Aortic Valve InsufficiencyRegurgitation3 moreThis trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Aortic Valve InsufficiencyAortic Valve Regurgitation6 moreThe purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Aortic Valve Replacement With Trifecta(TM)
Aortic Valve InsufficiencyRegurgitation3 moreTo confirm the clinical safety and effectiveness of the Trifecta valve.
Avr Thrombosis OutcoMe Study
Aortic StenosisThis study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) who are at risk of thrombosis, and relate this to clinical thrombotic and thromboembolic adverse events and subclinical valve thrombosis, and identify the timeframe of greatest risk for valve thrombosis.
The ReTAVI Prospective Observational Registry
Aortic Valve StenosisStructural Valve Deterioration1 morePatients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger & lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve [THV] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year.
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
Aortic StenosisTo confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.