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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 | Clinical Trials | Clareo Health

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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

Medtronic CoreValve® U.S. Pivotal Trial

NCT01240902•Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
•High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of \< 50%) at 30 days.
•Subject has senile degenerative aortic valve stenosis with: mean gradient \> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
•Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
•The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
•The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria

•Clinical
•Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
•Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)
•Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
•Untreated clinically significant coronary artery disease requiring revascularization.
•Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
•Need for emergency surgery for any reason.
•Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram.
•Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
•End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
+31 more criteria

Locations (45)

Banner Good Samaritan

Phoenix, Arizona, United States

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, United States

University of Southern California University Hospital

Los Angeles, California, United States

El Camino Hospital

Mountain View, California, United States

VA Palo Alto Health Care System

Palo Alto, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington Hospital Center / Georgetown Hospital

Washington D.C., District of Columbia, United States

University of Miami Health System / Jackson Memorial Hospital

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Key Dates

Start Date

December 10, 2010

Primary Completion Date

August 1, 2014

Completion Date

May 15, 2019

Last Updated

October 25, 2022

Enrollment

1,453

ACTUAL participants

Conditions

Severe Aortic Stenosis

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

DEVICE

Surgical Aortic Valve Replacement (SAVR)

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

ACTIVE_NOT_RECRUITINGNA

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).

NCT01586910

Severe Aortic Stenosis

View study

COMPLETED

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 25, 2022Data 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 Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

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

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).

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