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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

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ClinicalTrials.gov Identifier: NCT02701283
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Medtronic Transcatheter Aortic Valve Replacement Systems Device: Surgical Aortic Valve Replacement (SAVR) Not Applicable

Detailed Description:

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Study Start Date : March 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems
Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic Transcatheter Aortic Valve Replacement Systems
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

Active Comparator: Surgical Aortic Valve Replacement (SAVR)
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
Device: Surgical Aortic Valve Replacement (SAVR)
Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis




Primary Outcome Measures :
  1. All-cause mortality or disabling stroke [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. Composite of death, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) [ Time Frame: 30 days ]
  2. Number of patients with new permanent pacemaker implantation [ Time Frame: 30 days ]
  3. Number of patients with prosthetic valve endocarditis per the Duke criteria [ Time Frame: 1 year ]
  4. Prosthetic valve thrombosis [ Time Frame: 1 year ]
  5. All stroke (disabling and non-disabling) [ Time Frame: 1 year ]
  6. Number of patients with life-threatening bleed [ Time Frame: 1 year ]
  7. Number of patients with valve-related dysfunction requiring repeat procedure [ Time Frame: 1 year ]
  8. Number of patients with valve-related dysfunction (moderate or severe stenosis or regurgitation) [ Time Frame: 1 year ]
  9. Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) [ Time Frame: 1 year ]
  10. Number of patients with repeat hospitalization for signs and symptoms of aortic valve disease [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Health related quality of life assessed by EQ-5D Survey Instrument [ Time Frame: 1year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe aortic stenosis, defined as follows:

    1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography

    2. For asymptomatic patients:

      • Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography, OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography, AND a left ventricular ejection fraction <50%.
  2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
  3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
  2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

    1. aspirin or heparin (HIT/HITTS) and bivalirudin
    2. ticlopidine and clopidogrel
    3. Nitinol (titanium or nickel)
    4. contrast media
  3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  4. Ongoing sepsis, including active endocarditis.
  5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
  6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  11. Subject refuses a blood transfusion.
  12. 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).
  13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  14. 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.
  15. Currently participating in an investigational drug or another device trial (excluding registries).
  16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
  17. Need for emergency surgery for any reason.
  18. Subject is pregnant or breast feeding.
  19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  20. Pre-existing prosthetic heart valve in any position.
  21. Severe mitral regurgitation amenable to surgical replacement or repair.
  22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
  26. Prohibitive left ventricular outflow tract calcification.
  27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
  28. Aortic annulus diameter of <18 or >30 mm.
  29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:

  30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R TAV, or <6.0 mm for patent LIMA, or access vessel mean diameter <5.5 mm for Evolut 34R and TAVR 2.0 TAV or <6.0 mm for patent LIMA, or access vessel mean diameter <6 mm for CoreValve 31 mm TAV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701283


Contacts
Contact: Joleen Perkins 1-763-514-9731 joleen.perkins@medtronic.com
Contact: Jennifer Maloney +17635058644 jennifer.s.maloney@medtronic.com

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Locations
United States, Arizona
Abrazo Arizona Heart Hospital Recruiting
Phoenix, Arizona, United States, 85016
Principal Investigator: Timothy Byrne, MD         
Principal Investigator: Merick Kirshner, MD         
United States, California
Scripps Memorial Hospital La Jolla Recruiting
La Jolla, California, United States, 92037
Principal Investigator: Paul Teirstein, MD         
University of Southern California University Hospital Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Vaughn A. Starnes, MD         
Principal Investigator: Ray V. Matthews, MD         
El Camino Hospital Recruiting
Mountain View, California, United States, 64040
Principal Investigator: Ajanta De, MD         
Principal Investigator: Pei Tsau, MD         
Mercy General Hospital Recruiting
Sacramento, California, United States, 95816
Principal Investigator: Michael Chang, MD         
Principal Investigator: Frank Slachman, MD         
Los Robles Hospital & Medical Center Recruiting
Thousand Oaks, California, United States, 91360
Principal Investigator: Gregory Fontana, MD         
Principal Investigator: Vishva Dev, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: John Carroll, MD         
Principal Investigator: David Fullerton, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: John Forrest, MD         
Principal Investigator: Abeel Mangi, MD         
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Principal Investigator: Douglas Spriggs, MD         
Principal Investigator: Joshua Rovin, MD         
Delray Medical Center Recruiting
Delray Beach, Florida, United States, 33484
Principal Investigator: Brijeshwar Maini, MD         
Principal Investigator: Brian Bethea, MD         
HealthPark Medical Center Recruiting
Fort Myers, Florida, United States, 33908
Principal Investigator: Brian Hummel, MD         
Principal Investigator: Murali Mupalla, MD         
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Eduardo de Marchena, MD         
Principal Investigator: Donald Williams, MD         
Tallahassee Research Institute, Inc. Recruiting
Tallahassee, Florida, United States, 32308
Principal Investigator: Thomas Noel, MD         
Principal Investigator: Julian Hurt, MD         
United States, Georgia
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Principal Investigator: Christopher Meduri, MD         
Principal Investigator: James Kauten, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Principal Investigator: Ferdinand Leya, MD         
Principal Investigator: J. Michael Tuchek, DO         
United States, Indiana
Saint Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46290
Principal Investigator: James Hermiller, MD         
Principal Investigator: David Heimansohn, MD         
United States, Iowa
Mercy Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Principal Investigator: Atul Chawla, MD         
Principal Investigator: Bart Jenson, MD         
United States, Kansas
The University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Peter Tadros, MD         
Principal Investigator: George T. Zorn, MD         
United States, Kentucky
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: Kendra Grubb, MD         
Principal Investigator: Michael Flaherty, MD         
United States, Louisiana
Terrebonne General Medical Center Recruiting
Houma, Louisiana, United States, 70360
Principal Investigator: Peter Fail, MD         
Principal Investigator: Donald Netherland, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Bartley Griffith, MD         
Principal Investigator: Anuj Gupta, MD         
MedStar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Principal Investigator: John Wang, MD         
Principal Investigator: Michael Fiocco, MD         
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Jon Resar, MD         
Principal Investigator: Kaushik Mandal, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Ignacio Inglessis, MD         
Principal Investigator: Serguei Melnitchouk, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Jeffrey Popma, MD         
Principal Investigator: Kamal Khabbaz, MD         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Principal Investigator: Ashequl Islam, MD         
Principal Investigator: Joseph Flack, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Stanley Chetcuti, MD         
Principal Investigator: G. Michael Deeb, MD         
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Principal Investigator: Sanjay Batra, MD         
Principal Investigator: Thomas Davis, MD         
Spectrum Health Hospitals Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: William Merhi, DO         
Principal Investigator: John Heiser, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Paul Sorajja, MD         
Principal Investigator: Robert S. Farivar, MD         
United States, Missouri
Mercy Hospital Recruiting
Springfield, Missouri, United States, 65806
Principal Investigator: Robert Merritt, MD         
Principal Investigator: Sirish Parvathaneni, MD         
United States, New York
Saint Francis Hospital Recruiting
East Hills, New York, United States, 11548
Principal Investigator: George A. Petrossian, MD         
Principal Investigator: Newell B. Robinson, MD         
Saint Joseph's Hospital Health Center Recruiting
Liverpool, New York, United States, 13088
Principal Investigator: Ronald Caputo, MD         
Principal Investigator: Ayman Iskander, MD         
Northwell Health Recruiting
Manhasset, New York, United States, 11030
Principal Investigator: Bruce Rutkin, MD         
Principal Investigator: Rick Esposito, MD         
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Samin Sharma, MD         
Principal Investigator: David Adams, MD         
Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Frederick S. Ling, MD         
Principal Investigator: Peter Knight, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: J. Kevin Harrison, MD         
Principal Investigator: G. Charles Hughes, MD         
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: David Zhao, MD         
Principal Investigator: Neal Kon, MD         
United States, North Dakota
Sanford Medical Center Recruiting
Fargo, North Dakota, United States, 58122
Principal Investigator: Thomas A Haldis, MD         
Principal Investigator: Roxanne Newman, MD         
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Puvi Seshiah, MD         
Principal Investigator: Michael J Smith, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Alan Markowitz, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Scott Lilly         
Principal Investigator: Juan Crestanello, MD         
OhioHealth Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Principal Investigator: Steven Yakubov, MD         
Principal Investigator: Daniel Watson, MD         
United States, Oklahoma
Integris Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Principal Investigator: Jeffrey Sparling, MD         
Principal Investigator: Craig Elkins, MD         
United States, Oregon
Oregon Health Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Firas Zahr, MD         
Principal Investigator: Howard Song, MD         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Principal Investigator: David Cox, MD         
Principal Investigator: Raymond Singer, MD         
Geinsinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17043
Principal Investigator: Alfred Casale, MD         
Pinnacle Health Recruiting
Harrisburg, Pennsylvania, United States, 17043
Principal Investigator: Mubashir Mumtaz, M.D.         
Principal Investigator: Hemal Gada, M.D.         
University of Pittsburgh Medical Center UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Thomas G. Gleason, MD         
Principal Investigator: John Schindler, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Daniel Steinberg, MD         
Principal Investigator: Marc Katz, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Mark Robbins, MD         
Principal Investigator: Clayton Kaiser, MD         
United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75204
Principal Investigator: Robert C. Stoler, MD         
Principal Investigator: Robert F. Hebeler, MD         
Baylor Saint Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Joseph Coselli, MD         
Principal Investigator: Guilherme Silva, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael Reardon, MD         
Principal Investigator: Neal Kleiman, MD         
Methodist Hospital San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Jorge Alvarez, MD         
Principal Investigator: James Garrison, MD         
United States, Utah
University Hospital Salt Lake City Utah Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Frederick Welt, MD         
Principal Investigator: Jason Glotzbach, MD         
United States, Vermont
The University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Harold Dauerman, MD         
Principal Investigator: Frank Ittleman, MD         
United States, Virginia
Saint Mary's Hospital Recruiting
Richmond, Virginia, United States, 23226
Principal Investigator: Mark R. Bladergroen, MD         
Principal Investigator: David S. Lim, MD         
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Principal Investigator: Basel Ramlawi, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98124
Principal Investigator: Sameer Gafoor, MD         
Principal Investigator: Eric Lehr, MD         
United States, Wisconsin
Aurora Saint Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Principal Investigator: Tanvir Bajwa, MD         
Principal Investigator: Daniel O'Hair, MD         
Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Principal Investigator: Ravinay Bhindi, MD         
Principal Investigator: Peter Brady, MD         
Australia, Victoria
Monash Health Monash Heart Recruiting
Clayton, Victoria, Australia, 3168
Principal Investigator: Robert Gooley         
Principal Investigator: Julian Smith         
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Tony Walton         
Principal Investigator: David McGiffin         
Australia
Saint Vincent's Hospital (SVH) Recruiting
Darlinghurst, Australia, 2010
Principal Investigator: David Muller, MD         
Principal Investigator: Paul Jansz, MD         
Fiona Stanley Hospital (FSH) Recruiting
Murdoch, Australia, 6150
Principal Investigator: Gerald Yong, MD         
Principal Investigator: Robert Larbalestier, MD         
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: Bob Kiaii, MD         
Principal Investigator: Rodrigo Bagur, MD         
Toronto General Health Hospital Recruiting
Toronto, Ontario, Canada, MSG2C4
Principal Investigator: Eric Horlick, MD         
Principal Investigator: Chris Feindel, MD         
Canada, Quebec
Glen Royal Victoria (McGill) Recruiting
Montréal, Quebec, Canada, H4A 3J1
Principal Investigator: Nicolo Piazza         
Principal Investigator: Kevin Lachappelle         
Canada
Montreal Heart Recruiting
Montréal, Canada, H1T 1C8
Principal Investigator: Reda Ibrahim, MD         
Principal Investigator: Raymond Cartier, MD         
IUCPQ Recruiting
Quebec, Canada, G1V 4G5
Principal Investigator: Jospe Rodes-Cadau, MD         
Principal Investigator: Siamak Mohammadi, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Canada
Principal Investigator: Sam Rakhakrishnan, MD         
Principal Investigator: Stephen Fremes, MD         
France
Centre Hospitalier Régional Universitaire de Lille Recruiting
Lille, France, 59000
Principal Investigator: Thomas Modine, MD         
Principal Investigator: Arnaud Sudre, MD         
L'Hôpital Privé Jacques Cartier Massy Recruiting
Massy, France
Principal Investigator: Bernard Chevalier         
Principal Investigator: Arnaud Farge         
Clinique Pasteur Recruiting
Toulouse, France, 31300
Principal Investigator: Pierre Berthoumieu, MD         
Principal Investigator: Didier Tchetche, MD         
Netherlands
Academic Medical Center Amsterdam Not yet recruiting
Amsterdam, Netherlands
Principal Investigator: Prof. José Paulo Henriques         
Principal Investigator: Abdullah Kaya         
Catharina Ziekenhuis Recruiting
Eindhoven, Netherlands, 5623
Principal Investigator: W.A.L. (Pim) Tonino, MD         
Principal Investigator: Ka Yan Lam, MD         
St. Antonius Hospital Nieuwegein Recruiting
Nieuwegein, Netherlands
Principal Investigator: Jan Van der Heyden         
Principal Investigator: Robin Heijmen         
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015
Principal Investigator: Margreet Bekker, MD         
Principal Investigator: Nicolas van Mieghem, MD         
New Zealand
Waikato Hospital Recruiting
Hamilton, New Zealand
Principal Investigator: Sanjeevan Pasupati         
Principal Investigator: Adam El-Gamel         
Switzerland
UniversitätsSpital Zürich Recruiting
Zürich, Switzerland
Principal Investigator: Fabian Nietlispach         
Principal Investigator: Francesco Maisano         
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Jeffrey Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael Reardon, MD The Methodist Hospital System

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02701283     History of Changes
Other Study ID Numbers: 10234430Doc
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction