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).

This study is currently recruiting participants.
Verified April 2014 by Medtronic Cardiovascular
Information provided by (Responsible Party):
Medtronic Cardiovascular Identifier:
First received: April 24, 2012
Last updated: April 16, 2014
Last verified: April 2014

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.

Condition Intervention
Severe Aortic Stenosis
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Procedure: Surgical Aortic Valve Replacement (SAVR)

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 ]

    MACCE is defined as a composite of:

    • All-cause death
    • Myocardial infarction (MI)
    • All stroke, and
    • Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

  • 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 defined as follows:

    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch) and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation

      • Assessed acutely in resting state, either within 24-48 hours after the index procedure or before hospital discharge

  • 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 defined as a composite of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute kidney injury—Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
    • All-cause death

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

    Clinical efficacy defined as a composite of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
    • NYHA class III or IV
    • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA)≤ 0.9-1.1 cm2 and/or doppler velocity index(DVI) < 0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

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

    Time-Related Safety defined as a composite of:

    • Structural valve deterioration:

      • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤ 0.9-1.1 cm2 and/or DVI < 0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
      • Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thromboembolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)

Estimated Enrollment: 2500
Study Start Date: March 2012
Estimated Primary Completion Date: August 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)
Active Comparator: SAVR
Surgical Aortic Valve Replacement (SAVR)
Procedure: Surgical Aortic Valve Replacement (SAVR)


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must have STS mortality risk score ≥4% and ≤10%;
  • Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
  • Subject has severe aortic valve stenosis presenting with

    1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
    2. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 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;
  • 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 (including 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;
  • 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;
  • 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-ups 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;

Note: Additional anatomical and vascular exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its identifier: NCT01586910

Contact: Todd Fonseca
Contact: Francesca Barbieri, MD (EU only)

  Hide Study Locations
United States, California
Keck Medical Center of USC Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Ray Matthews, MD         
Principal Investigator: Vaughn A. Starnes, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: John Giacomini         
Principal Investigator: Thomas Burdon         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Ron Waksman         
Principal Investigator: Lowell Satler         
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Principal Investigator: Tomas A Salerno         
Principal Investigator: Eduardo de Marchena         
United States, Illinois
Loyola University of Chicago Recruiting
Mayowood, Illinois, United States, 60153
Principal Investigator: Mamdouh Bakhos         
Principal Investigator: Ferdinand (Fred) Leya         
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46290
Contact: R. Andrew Scroggs    317-583-5000      
Principal Investigator: David A Heimansohn         
Principal Investigator: James B Hermiller         
United States, Iowa
Iowa Heart Center / Mercy Medical Center Recruiting
West Des Moines, Iowa, United States, 50266
Principal Investigator: Atul Chawla, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: George "Trip" Zorn, MD         
Principal Investigator: Peter Tadros, MD         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Principal Investigator: Edgar Feinberg, II         
Principal Investigator: Peter S Fail         
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5864
Principal Investigator: Stanley J Chetcuti         
Principal Investigator: G. Michael Deeb         
Detroit Medical Center Recruiting
Detroit, Michigan, United States, 48201-2018
Principal Investigator: Theodore Schreiber         
Principal Investigator: Ali Kafi         
St. John Hospital & Medical Center Recruiting
Detroit, Michigan, United States, 48236
Principal Investigator: Thomas Davis         
Principal Investigator: Sanjay Batra         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: John C Heiser         
Principal Investigator: William Merhi         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Principal Investigator: John Brown, MD         
Principal Investigator: Robert Kipperman, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Susheel Kodali    212-305-7060      
Principal Investigator: Susheel Kodali         
Principal Investigator: Mathew Williams         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Brenda Kavanaugh    585-273-4956      
Principal Investigator: Peter A. Knight         
Principal Investigator: Frederick S. Ling         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: George C Hughes    919-668-0903      
Principal Investigator: J Kevin Harrison         
Principal Investigator: George C Hughes         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Robert J. Applegate, MD         
Principal Investigator: Neal D. Kon, MD         
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Contact: John R Robinson    513-862-3305      
Principal Investigator: Puvi Seshiah         
Principal Investigator: J Michael Smith         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Barry George, MD         
Principal Investigator: Juan Crestanelle, MD         
The OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Steven Yokubov         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Principal Investigator: Alfred Casale         
Principal Investigator: Kimberly Skelding         
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: Brijeshwar S Maini, MD         
Principal Investigator: Mubashir Mumtaz, MD         
United States, Texas
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Principal Investigator: Robert Hebeler, MD         
Principal Investigator: Robert Stoler, MD         
Methodist DeBakey Heart & Vascular Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael Reardon         
Principal Investigator: Neal Kleiman         
United States, Vermont
Fletcher Allen Health Care, Inc. Recruiting
Burlington, Vermont, United States, 05401
Contact: Kimberly Luebbers    802-847-0000      
Principal Investigator: Harold Dauermann         
Principal Investigator: Joseph Schmoker         
United States, Virginia
Sentara Cardiovascular Recruiting
Norfolk, Virginia, United States, 23507
Contact: Brent Beta    757-388-6144      
Principal Investigator: Paul Mahoney         
Principal Investigator: Jeff Rich         
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         
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada
Principal Investigator: Bob Kiaii         
Principal Investigator: Patrick Teefy         
Montreal Heart Institute Recruiting
Montreal, Canada
Principal Investigator: Anita Asgar, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Canada
Principal Investigator: Marino Labinaz, MD         
Principal Investigator: Marc Ruel, MD         
Rigshospitalet Recruiting
Copenhagen, Denmark
Principal Investigator: Lars Sondergaard, MD         
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Dominque Pon    +33 56 221 3131      
Principal Investigator: Jean Fajadet         
Principal Investigator: Olivier Vahdat         
Universitäts-Herzzentrum Freiburg • Bad Krozingen Recruiting
Bad Krozingen, Germany, 79106
Contact: Prof. Franz-Josef Neumann    07633-402-2000      
Principal Investigator: Professor Franz-Josef Neumann         
Principal Investigator: Professor Friedhelm Beyersdorf         
Universitätsklinikum Bonn Recruiting
Bonn, Germany
Contact: Prof. Dr. G Nickenig    0228 267 15127      
Principal Investigator: Professor Georg Nickenig         
Principal Investigator: Professor Armin Welz         
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany
Contact: R Lange         
Principal Investigator: Christian Hengstenberg         
Principal Investigator: S Bleiziffer         
Amphia Hospital Breda Recruiting
Breda, Netherlands
Principal Investigator: Peter den Heijer         
Principal Investigator: Mohamed Bentala         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Principal Investigator: Piet Boonstra, PhD         
Principal Investigator: A.J. van Boven, MD         
St. Antonius Hospital, R & D Cardiology Recruiting
Nieuwegein, Netherlands
Principal Investigator: J.M. ten Berg, MD         
Principal Investigator: R.H. Heijmen, MD, PhD         
Erasmus Medical Center - Rotterdam Recruiting
Rotterdam, Netherlands
Principal Investigator: A. Pieter Kappetein, MD, PhD         
Principal Investigator: Nicolas M. Van Mieghem, MD         
Servicio de Cardiologia del Hospital Virgen de la Victoria Recruiting
Malaga, Spain
Contact: Jose M Hernandez         
Principal Investigator: Jose M Hernandez         
Principal Investigator: Miguel Such         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain
Principal Investigator: Cesar Moris de La Tassa         
Principal Investigator: Juan Carlos Llosa Cortina         
Karolinska Universitetssjukhuset Stockholm Recruiting
Stockholm, Sweden, 171 76
Contact: Matthias Corbascio    +46 8 51770126      
Principal Investigator: Matthias Corbascio         
Principal Investigator: Andreas Rück         
Bern University Hospital Recruiting
Bern, Switzerland
Principal Investigator: Stephan Windecker, MD, PhD         
Principal Investigator: Thierry Carrel, PhD         
Universitatsspital Zurich Recruiting
Zurich, Switzerland
Principal Investigator: Volkmar Falk, MD, PhD         
Principal Investigator: Ronald Binder         
United Kingdom
Brighton & Sussex University Hospitals NHS Trust Recruiting
Brighton, United Kingdom
Contact: Scott Harreld    44 127 369 6955      
Principal Investigator: David Hildick-Smith         
Principal Investigator: Uday Trivedi         
Leeds General Infirmary Recruiting
Leeds, United Kingdom
Principal Investigator: Daniel Blackman         
Principal Investigator: Pankaj Kaul         
Glenfield Hospital, Leicester, UK Recruiting
Leicester, United Kingdom, LE5 4PW
Contact: David Hetmanski    +44 116 258 3256      
Principal Investigator: Prof. Tomasz Spyt         
Principal Investigator: Jan Kovac         
St. George's Hospital London Recruiting
London, United Kingdom, SW170QT
Contact: Lucy H H Parker    +44 208 266 6397      
Principal Investigator: Stephen Brecker         
Principal Investigator: Marjan Jahangiri         
Sponsors and Collaborators
Medtronic Cardiovascular
Study Chair: Patrick W. Serruys, MD, PhD Erasmus Medical Center
Study Chair: Nicolas M Van Mieghem, MD Erasmus Medical Center
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 Bad Nauheim
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 Mount Sinai School of Medicine
Principal Investigator: Jose M Hernandez Servicio de Cardiologia del Hospital Virgen de la Victoria
Principal Investigator: Miguel Such Servicio de Cardiologia del Hospital Virgen de la Victoria
  More Information

No publications provided by Medtronic Cardiovascular

Additional 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: April 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical processed this record on April 17, 2014