CLINICAL EVIDENCE COMPENDIUM TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

CoreValve ADVANCE

ADVANCE is a multicenter, prospective, single-arm, observational study to evaluate safety and performance of the CoreValve system in a routine hospital setting with results out to 5 years.

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CoreValve Continued Access Study

Patients underwent attempted implant under the same inclusion and exclusion criteria and trial procedures as the Pivotal trial.

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CoreValve Expanded Use STUDY

The purpose of this study was to evaluate the safety and effectiveness of the CoreValve system in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional comorbidities.

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CoreValve US Pivotal Extreme Risk TRIAL

The Extreme Risk CoreValve Pivotal Trial evaluated the safety and efficacy of the Medtronic CoreValve system for the treatment of patients with symptomatic severe aortic stenosis in whom the predicted risk of operative mortality or serious, irreversible morbidity was 50% or greater at 30 days.

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CoreValve US Pivotal High Risk Trial

The High Risk CoreValve Pivotal Trial is a prospective, randomized, multicenter, noninferiority trial to compare the safety and efficacy of the Medtronic CoreValve system to SAVR in patients with symptomatic severe aortic stenosis at increased surgical risk.

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Notion Trial

The Nordic Aortic Valve Intervention (NOTION) Trial randomized all-comers with severe native aortic valve stenosis to either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), including a lower-risk patient population from 3 centers in Denmark and Sweden.

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SURTAVI Trial

The SURTAVI Trial is a prospective, randomized, multicenter, noninferiority study to compare the safety and efficacy of the Medtronic TAVR system* to SAVR in patients with symptomatic severe aortic stenosis at intermediate surgical risk.

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Evolut R CE Mark Study

The Evolut R CE Mark Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients with symptomatic aortic stenosis and heart-team assessed risk of operative mortality.

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Evolut R FORWARD STUDY

The FORWARD Study is a prospective, single-arm, multicenter, observational study to assess the safety and clinical performance of the Medtronic Evolut R system in patients with symptomatic native aortic stenosis or failed bioprosthesis in routine practice.

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Evolut R US 34 mm Appendix Study

The Evolut R US Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery. As an appendix study, 60 patients were studied with the 34 mm valve.

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Evolut R US Study

The Evolut R U.S. Clinical Study is a prospective, multicenter, controlled, nonrandomized single-arm clinical study to evaluate the repositionable Evolut R system in patients deemed high or greater risk for surgery.  

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VIVA Study

VIVA is a prospective, observational, single-arm, post-market, multicenter study to collect data regarding use of TAVI with the CoreValve and Evolut R devices in patients with failing surgical aortic bioprostheses at high risk for re-do open-heart surgery.

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SURTAVI Continued Access Study

Patients underwent attempted TAV implant under the same inclusion and exclusion criteria and trial procedures as the SURTAVI Trial, with no randomization to surgery.^†

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Evolut PRO Study

The Evolut PRO Study is a prospective, multicenter, controlled, non-randomized single-arm study. Primary safety endpoints were all cause mortality and disabling stroke at 30 days, and the primary efficacy endpoint was percentage of patients with no or trace aortic regurgitation at 30 days.

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