Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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). (SURTAVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular Identifier:
First received: April 24, 2012
Last updated: October 12, 2016
Last verified: October 2016

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 sever symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Condition Intervention
Severe Aortic Stenosis
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Procedure: Surgical Aortic Valve Replacement (SAVR) (Not applicable for Single Arm)
Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Resource links provided by NLM:

Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • All-cause mortality or disabling stroke [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    All-cause mortality or disabling stroke

Secondary Outcome Measures:
  • Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

  • The occurrence of individual MACCE components [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Major Adverse Events (MAE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Conduction disturbance requiring permanent pacemaker implantation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Change in NYHA class from baseline [ Time Frame: Baseline through 5 years ] [ Designated as safety issue: No ]
  • Change in distance walked during 6-minute walk test (6MWT) [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
  • Ratio of days alive out of hospital versus total days alive [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) change from baseline [ Time Frame: Baseline through 5 years ] [ Designated as safety issue: No ]
  • Echocardiographic assessment of prosthetic valve performance [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Measured by transvalvular mean gradient, effective orifice area and degree of prosthetic aortic valve regurgitation (transvalvular and paravalvular)

  • Aortic valve disease related hospitalizations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cardiovascular deaths and valve-related deaths [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stroke and TIAs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Peri-procedural neurological injury [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Index procedure related major adverse events (MAEs) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]
  • Length of index procedure hospital stay [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: No ]
  • Presence of atrial fibrillation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Device success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]
    Device success

  • Procedural success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]
    Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)

  • Evidence of prosthetic valve dysfunction (Medtronic CoreValve® System subjects only) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of Early Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Incidence of Early safety at 30 days

  • Incidence of Clinical Efficacy (after 30 days) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Clinical efficacy

  • Incidence of Time-Related Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Time-Related Safety

  • Resheath and recapture scuccess (Evolut R only) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: March 2012
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medtronic CoreValve® System TAVI
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: SAVR
Surgical Aortic Valve Replacement (SAVR) (Not applicable for Single Arm)
Procedure: Surgical Aortic Valve Replacement (SAVR) (Not applicable for Single Arm)


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   All
Accepts 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 elgibility 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01586910

Contact: Mike Boulware
Contact: Maarten Hollander (EU)

  Hide Study Locations
United States, Arizona
Banner Good Samaritan Medical Center Active, not recruiting
Phoenix, Arizona, United States, 85006
United States, California
Cedars-Sinai Medical Center Active, not recruiting
Hollywood, California, United States, 90048
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Paul Teirstein, MD         
Principal Investigator: Jeffrey Tyner, MD         
Keck Medical Center of USC Active, not recruiting
Los Angeles, California, United States, 90033
El Camino Hospital Active, not recruiting
Mountain View, California, United States, 94040
VA Palo Alto Health Care System Active, not recruiting
Palo Alto, California, United States, 94304
Southern California Permenente Medical Group Active, not recruiting
Pasadena, California, United States, 91101
Mercy General Withdrawn
Sacremento, California, United States, 95819
Stanford University Medical Center Active, not recruiting
Stanford, California, United States, 94305
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Principal Investigator: Raymond McKay, MD         
Principal Investigator: Robert Hagberg, MD         
Yale New Haven Hospital Active, not recruiting
New Haven, Connecticut, United States, 06520-8047
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Ron Waksman, MD         
Principal Investigator: Ammar Bafi, MD         
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Lang Lin, MD         
Principal Investigator: Joshua Rovin, MD         
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Principal Investigator: Tomas A Salerno, MD         
Principal Investigator: Eduardo de Marchena, MD         
Delray Medical Center Active, not recruiting
Delray Beach, Florida, United States, 33484
United States, Georgia
Emory University Active, not recruiting
Atlanta, Georgia, United States, 30308
Piedmont Healthcare, Inc. Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Principal Investigator: Jeffrey Lau, MD         
Principal Investigator: Christian Spies, MD         
United States, Illinois
Loyola University of Chicago Active, not recruiting
Mayowood, Illinois, United States, 60153
United States, Indiana
St. Vincent Heart Center of Indiana Active, not recruiting
Indianapolis, Indiana, United States, 46290
United States, Iowa
Iowa Heart Center / Mercy Medical Center Recruiting
West Des Moines, Iowa, United States, 50266
Principal Investigator: Atul Chawla, MD         
Principal Investigator: David Hockmuth, MD         
United States, Kansas
University of Kansas Hospital Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky Withdrawn
Lexington, Kentucky, United States, 40536
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Principal Investigator: Edgar Feinberg, II, MD         
Principal Investigator: Peter S Fail, MD         
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Principal Investigator: Jon Resar, MD         
Principal Investigator: John Conte, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center, Inc. Active, not recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health Systems Active, not recruiting
Ann Arbor, Michigan, United States, 48109-5864
Detroit Medical Center Active, not recruiting
Detroit, Michigan, United States, 48201-2018
Henry Ford Active, not recruiting
Detroit, Michigan, United States, 48202
St. John Hospital & Medical Center Recruiting
Detroit, Michigan, United States, 48236
Principal Investigator: Thomas Davis, MD         
Principal Investigator: Sanjay Batra, MD         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: John C Heiser, MD         
Principal Investigator: William Merhi, MD         
United States, Minnesota
Abbott NW - MN Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Paul Sorajja, MD         
Principal Investigator: Benjamin Sun, MD         
Mayo Clinic - St. Mary's Hospital Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Hospital/MAHI Active, not recruiting
Kansas City, Missouri, United States, 64111
United States, Nebraska
Alegent Creighton Health Research Center Active, not recruiting
Omaha, Nebraska, United States, 68124
United States, New Jersey
Cooper University Hospital Active, not recruiting
Camden, New Jersey, United States, 08103
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Principal Investigator: John Brown, MD         
Principal Investigator: Robert Kipperman, MD         
United States, New York
University at Buffalo Withdrawn
Buffalo, New York, United States, 14426
North Shore University Hospital Active, not recruiting
Manhasset, New York, United States, 11030
Winthrop University Hospital Active, not recruiting
Mineola, New York, United States, 11501
New York University School of Medicine Active, not recruiting
New York, New York, United States, 10016
Mount Sinai School of Medicine Active, not recruiting
New York, New York, United States, 10029
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Susheel Kodali    212-305-7060      
Principal Investigator: Susheel Kodali, MD         
Principal Investigator: Isaac George, MD         
Lenox Hill Hospital Active, not recruiting
New York, New York, United States, 10075
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Brenda Kavanaugh    585-273-4956      
Principal Investigator: Peter A. Knight, MD         
Principal Investigator: Frederick S. Ling, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Principal Investigator: George Petrossian, MD         
Principal Investigator: Newell Robinson, MD         
United States, North Carolina
Carolinas HealthCare System Active, not recruiting
Charlotte, North Carolina, United States, 28203
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Good Samaritan Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45220
University Hospitals Case Medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
The Ohio State University Active, not recruiting
Columbus, Ohio, United States, 43210
The OhioHealth Research Institute Active, not recruiting
Columbus, Ohio, United States, 43214
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Oklahoma, Oklahoma, United States, 73120
Principal Investigator: Mohammad K.J. Ghani, MD         
Principal Investigator: Robert Mark Bodenhamer, MD         
United States, Pennsylvania
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822
University of Pennsylvania Health System Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Thomas Gleason, MD         
Principal Investigator: Joon Sup Lee, MD         
Pinnacle Health Cardiovascular Institute Recruiting
Wormsleyburg, Pennsylvania, United States, 17043
Principal Investigator: William Bachinsky, MD         
Principal Investigator: Mubashir Mumtaz, MD         
United States, Tennessee
Baptist Memorial Hospital Memphis Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Basil M Paulus, MD         
Principal Investigator: H. Edward Garrett, Jr, MD         
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Principal Investigator: Robert Hebeler, MD         
Principal Investigator: Robert Stoler, MD         
Medical City Hospital - Dallas Withdrawn
Dallas, Texas, United States, 75230
The Methodist DeBakey Heart & Vascular Center Active, not recruiting
Houston, Texas, United States, 77030
The Heart Hospital - Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
United States, Utah
Intermountain Medical Center Active, not recruiting
Murray, Utah, United States, 84107
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Kimberly Luebbers    802-847-0000      
Principal Investigator: Harold Dauermann, MD         
Principal Investigator: Joseph Schmoker, MD         
United States, Virginia
Sentara Cardiovascular Active, not recruiting
Norfolk, Virginia, United States, 23507
Bon Secours St. Mary's Hospital Active, not recruiting
Richmond, Virginia, United States, 23226
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Daniel O'Hair, MD         
Principal Investigator: Tanvir Bajwa, MD         
Universitair Ziekenhuis Antwerpen Withdrawn
Edegem, Belgium
Canada, Ontario
London Health Sciences Centre, University Hospital Active, not recruiting
London, Ontario, Canada
Sunnybrook Research Institute Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital (University Health Network) Active, not recruiting
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
McGill University Health Center - Royal Victoria Hospital Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Montreal Heart Institute Active, not recruiting
Montreal, Canada
University of Ottawa Heart Institute Withdrawn
Ottawa, Canada
Rigshospitalet Active, not recruiting
Copenhagen, Denmark
Clinique Pasteur Withdrawn
Toulouse, France, 31076
Universitäts-Herzzentrum Freiburg • Bad Krozingen Active, not recruiting
Bad Krozingen, Germany, 79106
Universitätsklinikum Bonn Active, not recruiting
Bonn, Germany
Deutsches Herzzentrum Muenchen Active, not recruiting
Munich, Germany
Amphia Hospital Breda Active, not recruiting
Breda, Netherlands
Medisch Centrum Leeuwarden Active, not recruiting
Leeuwarden, Netherlands
St. Antonius Hospital, R & D Cardiology Active, not recruiting
Nieuwegein, Netherlands
Erasmus Medical Center - Rotterdam Active, not recruiting
Rotterdam, Netherlands
Servicio de Cardiologia del Hospital Virgen de la Victoria Active, not recruiting
Malaga, Spain
Hospital Universitario Central de Asturias Active, not recruiting
Oviedo, Spain
Karolinska Universitetssjukhuset Stockholm Active, not recruiting
Stockholm, Sweden, 171 76
Bern University Hospital Active, not recruiting
Bern, Switzerland
Universitatsspital Zurich Active, not recruiting
Zurich, Switzerland
United Kingdom
Brighton & Sussex University Hospitals NHS Trust Withdrawn
Brighton, United Kingdom
Leeds General Infirmary Active, not recruiting
Leeds, United Kingdom
Glenfield Hospital, Leicester, UK Active, not recruiting
Leicester, United Kingdom, LE5 4PW
St. George's Hospital London Active, not recruiting
London, United Kingdom, SW170QT
Sponsors and Collaborators
Medtronic Cardiovascular
Principal Investigator: Stephan Windecker, MD, PhD Bern University Hospital
Principal Investigator: A. Pieter Kappetein, MD, PhD Erasmus Medical Center
Principal Investigator: Rüdiger Lange, MD, PhD Deutsches Herzzentrum München
Principal Investigator: Thomas Walther, MD, PhD Kerckhoff Klinik
Principal Investigator: Jeffrey J. Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael J. Reardon, MD The Methodist Hospital System
Principal Investigator: David H. Adams, MD Icahn School of Medicine at Mount Sinai
Study Chair: Nicolas M. Van Mieghem, MD Erasmus Medical Center
Study Chair: Patrick W. Serruys, MD, PhD National Heart & Lung Institute of Imperial College in London
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular Identifier: NCT01586910     History of Changes
Other Study ID Numbers: IDE #G120169 
Study First Received: April 24, 2012
Last Updated: October 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on January 14, 2017