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Active clinical trials for "Aortic Valve Stenosis"

Results 381-390 of 802

Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access

Aortic Valve Stenosis

Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System

Completed56 enrollment criteria

Inflammatory Response to Aortic Valve Replacement

Aortic Valve Stenosis

A 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.

Completed2 enrollment criteria

TAVI Without Balloon Predilatation (of the Aortic Valve ) SAPIEN 3

Aortic Valve Stenosis

Balloon 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.

Completed21 enrollment criteria

PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves...

Aortic Valve Stenosis

A 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.

Completed7 enrollment criteria

An Observational, Prospective Evaluation of the Trifecta™ Valve

Aortic Valve InsufficiencyRegurgitation3 more

This 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.

Completed16 enrollment criteria

Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Aortic Valve InsufficiencyAortic Valve Regurgitation6 more

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

Completed15 enrollment criteria

Aortic Valve Replacement With Trifecta(TM)

Aortic Valve InsufficiencyRegurgitation3 more

To confirm the clinical safety and effectiveness of the Trifecta valve.

Completed14 enrollment criteria

Avr Thrombosis OutcoMe Study

Aortic Stenosis

This 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.

Not yet recruiting16 enrollment criteria

The ReTAVI Prospective Observational Registry

Aortic Valve StenosisStructural Valve Deterioration1 more

Patients 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.

Not yet recruiting12 enrollment criteria

Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

Aortic Stenosis

To 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.

Completed35 enrollment criteria
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