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).
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)Surgical Aortic Valve Replacement (SAVR)Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Study 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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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);
* Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
* Subject refuses a blood transfusion;
* Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
* Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
* Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
* Currently participating in an investigational drug or another device trial (excluding registries);
* Evidence of an acute myocardial infarction ≤30 days before the index procedure;
* Need for emergency surgery for any reason;
* True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
* Extensive mediastinal radiation;
* Liver failure (Child-C);
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram;
* Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm);
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
* End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min;
* Pulmonary Hypertension (systolic pressure\> 80mmHg);
* Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc;
* Frailty assessments identify:
1. Subject is \< 80 years of age and three or more of the following apply
2. Subject is ≥ 80 years of age and two or more of the following apply
* Wheelchair bound
* Resides in an institutional care facility (e.g., nursing home, skilled care center)
* Body Mass Index \< 20 kg/m2
* Grip Strength \< 16 kg
* Katz Index Score ≤ 4
* Albumin \< 3.5 g/dL;
* Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)
Note: Additional anatomical and vascular exclusion criteria may apply.
Note: \* For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.
Primary outcome measure(s)
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability — 24 months All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths.
Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
Trial sites (86)
Facility
City
Region
Status
Banner Good Samaritan Medical Center
Phoenix
Arizona
Cedars-Sinai Medical Center
Hollywood
California
Scripps Green Hospital
La Jolla
California
Keck Medical Center of USC
Los Angeles
California
El Camino Hospital
Mountain View
California
VA Palo Alto Health Care System
Palo Alto
California
Southern California Permenente Medical Group
Pasadena
California
Stanford University Medical Center
Stanford
California
Hartford Hospital
Hartford
Connecticut
Yale New Haven Hospital
New Haven
Connecticut
Washington Hospital Center
Washington D.C.
District of Columbia
Morton Plant Hospital
Clearwater
Florida
University of Miami
Coral Gables
Florida
Delray Medical Center
Delray Beach
Florida
Emory University
Atlanta
Georgia
Piedmont Healthcare, Inc.
Atlanta
Georgia
The Queen's Medical Center
Honolulu
Hawaii
Loyola University of Chicago
Maywood
Illinois
St. Vincent Heart Center of Indiana
Indianapolis
Indiana
Iowa Heart Center / Mercy Medical Center
West Des Moines
Iowa
University of Kansas Hospital
Kansas City
Kansas
Cardiovascular Institute of the South
Houma
Louisiana
The Johns Hopkins University
Baltimore
Maryland
Beth Israel Deaconess Medical Center, Inc.
Boston
Massachusetts
University of Michigan Health Systems
Ann Arbor
Michigan
Detroit Medical Center
Detroit
Michigan
Henry Ford
Detroit
Michigan
St. John Hospital & Medical Center
Detroit
Michigan
Spectrum Health Hospitals
Grand Rapids
Michigan
Abbott NW - MN Heart Institute Foundation
Minneapolis
Minnesota
Mayo Clinic - St. Mary's Hospital
Rochester
Minnesota
Saint Luke's Hospital/MAHI
Kansas City
Missouri
Alegent Creighton Health Research Center
Omaha
Nebraska
Cooper University Hospital
Camden
New Jersey
Morristown Medical Center
Morristown
New Jersey
North Shore University Hospital
Manhasset
New York
Winthrop University Hospital
Mineola
New York
New York University School of Medicine
New York
New York
Mount Sinai School of Medicine
New York
New York
Columbia University Medical Center
New York
New York
+ 46 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.