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Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). | Clinical Trials | Clareo Health

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Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

NCT01586910•Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
•Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
•Subject has severe aortic stenosis presenting with;
•1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
•2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25;
•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
•Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
•Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria

•Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
•Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
•A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
•Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
•Ongoing sepsis, including active endocarditis;
•Any condition considered a contraindication to extracorporeal assistance;
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
•Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*;
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
•Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
+29 more criteria

Locations (86)

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Cedars-Sinai Medical Center

Hollywood, California, United States

Scripps Green Hospital

La Jolla, California, United States

Keck Medical Center of USC

Los Angeles, California, United States

El Camino Hospital

Mountain View, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Southern California Permenente Medical Group

Pasadena, California, United States

Stanford University Medical Center

Stanford, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

July 1, 2018

Completion Date

November 1, 2026

Last Updated

October 28, 2025

Enrollment

1,746

ACTUAL participants

Conditions

Severe Aortic Stenosis

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

Surgical Aortic Valve Replacement (SAVR)

PROCEDURE

Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

NCT06136429

Severe Aortic Stenosis

View study

COMPLETED

Alwide Plus China Post-market Clinical Investigation

NCT07304427

Severe Aortic StenosisTranscatheter Aortic Valve Replacemen

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Single-arm Study to Evaluate a Transcatheter Aortic Valve System Safety and Efficacy for the Treatment of Patients With Severe Aortic Stenosis

Alwide Plus China Post-market Clinical Investigation

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

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