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. (see Contacts and Locations)
Verified August 2014 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01586910
First received: April 24, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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

  • 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


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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Team unanimously agree on Intermediate Risk classification;
  • Subject has severe aortic valve stenosis;
  • 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;
  • 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
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 ClinicalTrials.gov identifier: NCT01586910

Contacts
Contact: Erin McDowell (US) surtavi@medtronic.com
Contact: Maarten Hollander (EU) surtavi@medtronic.com

  Hide Study Locations
Locations
United States, Arizona
Banner Good Samaritan Medical Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: NA         
Principal Investigator: Timothy Byrne, DO         
Principal Investigator: Michael Caskey, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Hollywood, California, United States, 90048
Principal Investigator: Raj Makkar, MD         
Principal Investigator: Wen Chang, MD         
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 Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Ray Matthews, MD         
Principal Investigator: Vaughn A. Starnes, MD         
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Principal Investigator: James Joye, MD         
Principal Investigator: Vincent Gaudiani, MD         
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: John Giacomini, MD         
Principal Investigator: Thomas Burdon, MD         
Southern California Permenente Medical Group Recruiting
Pasadena, California, United States, 91101
Contact: NA         
Principal Investigator: Vicken Aharonian, MD         
Principal Investigator: Thomas Pfeffer, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: NA         
Principal Investigator: Raymond McKay, MD         
Principal Investigator: Robert Hagberg, MD         
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520-8047
Contact: NA         
Principal Investigator: Michael Cleman, MD         
Principal Investigator: Sabet Hashim, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Ron Waksman, MD         
Principal Investigator: Lowell Satler, MD         
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33146
Principal Investigator: Tomas A Salerno, MD         
Principal Investigator: Eduardo de Marchena, MD         
United States, Georgia
Piedmont Healthcare, Inc. Recruiting
Atlanta, Georgia, United States, 30309
Contact: NA         
Principal Investigator: James Kauten, MD         
Principal Investigator: Vivek Rajagopal, MD         
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: NA         
Principal Investigator: Vasilis Babliaros, MD         
Principal Investigator: Vinod Thourani, MD         
United States, Illinois
Loyola University of Chicago Recruiting
Mayowood, Illinois, United States, 60153
Principal Investigator: Mamdouh Bakhos, MD         
Principal Investigator: Ferdinand (Fred) Leya, MD         
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, MD         
Principal Investigator: James B Hermiller, MD         
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 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, MD         
Principal Investigator: Peter S Fail, MD         
United States, Maryland
The Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: NA         
Principal Investigator: Jon Resar, MD         
Principal Investigator: John Conte, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center, Inc. Recruiting
Boston, Massachusetts, United States, 02215
Contact: NA         
Principal Investigator: Jeffrey Popma, MD         
Principal Investigator: Kamal Khabbaz, MD         
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5864
Principal Investigator: Stanley J Chetcuti, MD         
Principal Investigator: G. Michael Deeb, MD         
Detroit Medical Center Recruiting
Detroit, Michigan, United States, 48201-2018
Principal Investigator: Theodore Schreiber, MD         
Principal Investigator: Scott E. Henry, MD         
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 Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Gurpreet Sandhu, MD         
Principal Investigator: Alberto Pochettino, MD         
United States, Nebraska
Alegent Creighton Health Research Center Recruiting
Omaha, Nebraska, United States, 68124
Principal Investigator: Ruby Satpathy, MD         
Principal Investigator: Thomas Langdon, MD         
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
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: NA         
Principal Investigator: Alan Hartman, MD         
Principal Investigator: Stanley Katz, MD         
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: Mathew Williams, MD         
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: NA         
Principal Investigator: Carlos Ruiz, MD         
Principal Investigator: Gregory Fontana, MD         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: NA         
Principal Investigator: David Adams, MD         
Principal Investigator: Samin Sharma, MD         
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: NA         
Principal Investigator: James Slater, MD         
Principal Investigator: Aubrey Galloway, MD         
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
Contact: NA         
Principal Investigator: George Petrossian, MD         
Principal Investigator: Newell Robinson, MD         
United States, North Carolina
Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: NA         
Principal Investigator: Michael Rinaldi, MD         
Principal Investigator: Eric Skipper, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: George C Hughes    919-668-0903      
Principal Investigator: J Kevin Harrison, MD         
Principal Investigator: George C Hughes, MD         
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, MD         
Principal Investigator: J Michael Smith, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: NA         
Principal Investigator: Alan Markowitz, MD         
Principal Investigator: Marco Costa, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Barry George, MD         
Principal Investigator: Juan Crestanello, MD         
The OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Steven Yakubov, MD         
Principal Investigator: Daniel Watson, MD         
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 Recruiting
Danville, Pennsylvania, United States, 17822
Principal Investigator: Alfred Casale, MD         
Principal Investigator: Kimberly Skelding, MD         
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: NA         
Principal Investigator: Howard Herrmann, MD         
Principal Investigator: Joseph Bavaria, MD         
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, 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 Recruiting
Nashville, Tennessee, United States, 37232
Contact: NA         
Principal Investigator: Mark Robbins, MD         
Principal Investigator: Stephen Ball, 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         
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: NA         
Principal Investigator: David Brown, MD         
Principal Investigator: William Ryan, MD         
Methodist DeBakey Heart & Vascular Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael Reardon, MD         
Principal Investigator: Neal Kleiman, MD         
CRSTI/The Heart Hospital - Baylor Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: David Brown, MD         
Principal Investigator: William Ryan, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: NA         
Principal Investigator: Brian Whisenant, MD         
United States, Vermont
Fletcher Allen Health Care, Inc. 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 Recruiting
Norfolk, Virginia, United States, 23507
Contact: Brent Beta    757-388-6144      
Principal Investigator: Paul Mahoney, MD         
Principal Investigator: Jeff Rich, MD         
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         
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium
Contact: Van Breusegem         
Principal Investigator: Prof. Inez Rodrigus         
Principal Investigator: Prof. Johan Bosmans         
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada
Principal Investigator: Bob Kiaii         
Principal Investigator: Patrick Teefy         
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Michael Julius    416-480-4560      
Principal Investigator: Sam Radhakrishnan, MD         
Principal Investigator: Stephen Fremes, MD         
Toronto General Hospital (University Health Network) Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Eric Horlick    416-340-3835      
Contact: Chris Feindel         
Principal Investigator: Eric Horlick, MD         
Canada, Quebec
McGill University Health Center - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: Nicolo Piazza, MD         
Principal Investigator: Benoit de Varennes, MD         
Canada
Montreal Heart Institute Recruiting
Montreal, Canada
Principal Investigator: Anita Asgar, MD         
Principal Investigator: Raymond Cartier, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Canada
Principal Investigator: Marino Labinaz, MD         
Principal Investigator: Marc Ruel, MD         
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Principal Investigator: Lars Sondergaard, MD         
France
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Dominque Pon    +33 56 221 3131      
Principal Investigator: Jean Fajadet         
Principal Investigator: Olivier Vahdat         
Germany
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         
Netherlands
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         
Spain
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         
Sweden
Karolinska Universitetssjukhuset Stockholm Recruiting
Stockholm, Sweden, 171 76
Contact: Matthias Corbascio    +46 8 51770126      
Principal Investigator: Matthias Corbascio         
Principal Investigator: Andreas Rück         
Switzerland
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
Investigators
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
  More Information

No publications provided by Medtronic Cardiovascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01586910     History of Changes
Other Study ID Numbers: IDE #G120169
Study First Received: April 24, 2012
Last Updated: August 14, 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

ClinicalTrials.gov processed this record on September 11, 2014