Trial record 1 of 1 for:    NCT01314313
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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01314313
First received: March 7, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.


Condition Intervention Phase
Symptomatic Severe Aortic Stenosis
Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [Edwards Study 2010-12]

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • Cohort A: Non-hierarchical composite of death and disabling stroke [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Cohort B: Non-hierarchical composite of death (all cause), disabling stroke and repeat hospitalization [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
  • PIIS3 High Risk Cohort/NR7: Non-hierarchical composite event of death, all stroke, and aortic insufficiency. [ Time Frame: Effectiveness time frame 1 year and safety 30 days ] [ Designated as safety issue: Yes ]
    PIIS3 High Risk Cohort: Non-inferiority analysis to historical control.

  • PIIS3 Intermediate Risk Cohort/NR8: Non-hierarchical composite endpoints of death and all stroke (effectiveness) and death, all stroke, major bleeding and major vascular complications (safety) [ Time Frame: Effectiveness time frame 1 year and safety 30 days ] ] [ Designated as safety issue: Yes ]
    PIIS3 intermediate risk cohort: Non-inferiority analysis to historical controls.

  • NR1,NR3-NR6: Freedom from mortality at 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • NR2: Freedom from mortality, major vascular complications and major bleeding. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5550
Study Start Date: March 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAPIEN XT™ valve with the NovaFlex or NovaFlex+ delivery syst Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable: SAPIEN XT™ vs. AVR; Inoperable: SAPIEN XT™ vs. SAPIEN®
Experimental: SAPIEN XT™ valve with the Ascendra2 and Ascendra+ Delivery Sys Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable: SAPIEN XT ™vs. AVR
Active Comparator: SAPIEN® valve with the RetroFlex3™ delivery system Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Inoperable: SAPIEN XT™ vs. SAPIEN®
Active Comparator: AVR with a surgical bioprosthetic heart valve Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable: SAPIEN XT™ vs. AVR
Experimental: SAPIEN 3™valve with the Commander Delivery System Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
High risk: SAPIEN 3™ vs. historical control; Intermediate risk: SAPIEN 3™ vs. historical control
Experimental: SAPIEN 3™ valve with the Certitude Delivery System Device: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
High risk: SAPIEN 3™ vs. historical control Intermediate risk: SAPIEN 3™ vs. historical control

Detailed Description:

A prospective multi-center trial of patients undergoing aortic valve replacement for severe aortic stenosis. Patient cohorts will include the following groups based on operative risk for surgical aortic valve replacement: inoperable, high surgical risk (STS ≥ 8%), and intermediate risk (STS = 4-8%).

The Edwards SAPIEN XT transcatheter heart valve (THV) system will be studied in patients deemed inoperable or intermediate risk. A subset of inoperable patients will be randomized to receive transcatheter aortic valve replacement (TAVR) with either the SAPIEN XT THV or the SAPIEN THV. The SAPIEN XT will be studied in intermediate risk patients randomized to receive TAVR with the SAPIEN XT or surgical AVR.

The Edwards SAPIEN 3 THV will be studied in a non-randomized fashion in patients from all three risk groups.

Data will be collected from all patients for up to five years following the valve replacement procedure.

  Eligibility

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

Inclusion Criteria

All Candidates for this study (Cohorts A, B and S3) must meet the following criteria:

  1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.

Once eligibility in accordance to the above criteria is established, patients are assessed for operability (in-operable, high risk, intermediate risk). All candidates must meet the above criteria in order to be stratified into Cohort A, Cohort B or S3.

Additional Eligibility Criteria Specific to Cohort A:

Inclusion Criteria:

  1. STS ≥ 4
  2. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR or AVR is appropriate
  3. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present)
  4. Study patient agrees to undergo surgical aortic valve replacement (AVR) - if randomized to control treatment

Additional Eligibility Criteria Specific to Cohort B

Inclusion Criteria:

  1. The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity is ≥ 50%.
  2. The heart team agrees the patient is likely to benefit from valve replacement.

Additional Eligibility Criteria Specific to the PIIS3 High Risk Cohort/ NR7

Inclusion Criteria:

  1. STS > 8
  2. For inoperable patients: Same as #1 for additional eligibility criteria specific to Cohort B
  3. Aortic valve annulus area range (273mm2-680 mm2) per 3D imaging (echo, CT or MRI).

Additional Eligibility Criteria Specific to the PIIS3 Intermediate Risk Cohort/ NR8

Inclusion Criteria:

  1. Assessment of Intermediate surgical risk define as STS 4-8% or Heart Team assessment of intermediate risk factors.
  2. Aortic valve annulus area range (273 mm2-680 mm2) per 3D imaging (echo, CT, or MRI).
  3. Heart team agrees (a priori) on treatment strategy for concomitant coronary disease (if present).

Exclusion Criteria

Exclusion Criteria for Cohort A, Cohort B and the S3 Cohorts (including NR7 and NR8):

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Preexisting mechanical or bioprosthetic valve in any position (NR3).
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
  6. Any patient with a balloon valvuloplasty (BAV) within 30 days of the procedure (unless BAV is a bridge to procedure after a qualifying ECHO).
  7. Patient with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation.
  8. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Pit < 50,000 cell/mL).
  9. Hypertrophic cardiomyopathy with or without obstruction (HOCM).
  10. Severe ventricular dysfunction with LVEF < 20%.
  11. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
  12. Active upper GI bleeding within 3 months (90 days) prior to procedure.
  13. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
  14. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure.
  15. Renal insufficiency (creatinine> 3.0 mg/dL) and/or renal replacement therapy at the time of screening.
  16. Estimated life expectancy < 24 months (730 days) due carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
  17. Expectation that patient will not improve despite treatment of aortic stenosis.
  18. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  19. It is known that the patient is currently enrolled in The PARTNER I Trial.
  20. Active bacterial endocarditis within 6 months (180 days) of procedure.

Exclusion Criteria Specific to Cohort A:

  1. Heart team assessment of inoperability (including examining cardiac surgeon).
  2. Complex coronary artery disease:

    • Unprotected left main coronary artery
    • Syntax score> 32 (in the absence of prior revascularization)
  3. Native aortic annulus size < 18 mm or> 27 mm as measured by echocardiogram.
  4. Patient refuses aortic valve replacement surgery.

Exclusion Criteria Specific to Cohort B and the S3 Cohorts (including NR7 and NR8):

  1. Heart team assessment of inoperability (including examining cardiac surgeon). PIIS3 intermediate risk cohort and NR8 only.
  2. Untreated clinically significant coronary artery disease requiring revascularization. Cohort B,PIIS3 high risk cohort and NR7 only.
  3. Complex coronary artery disease (S3i and NR8 only):

    1. Unprotected left main coronary artery
    2. Syntax score > 32 (in the absence of prior revascularization)
  4. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
  5. Need for emergency surgery for any reason.
  6. Native aortic annulus size < 18 mm or > 25 mm for Cohort B and <16mm or >28mm for the S3 Cohort (including NR7 and NR8), as measured by echocardiogram.
  7. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (Transfemoral).
  8. Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F for Cohort B and 14F or 16F for the S3 Cohorts (including NR7/NR8) introducer sheath such as severe obstructive calcification. Severe tortuosity or minimum average vessel size less than 7 mm (5.5 mm S3 Cohorts and NR7/NR) (Transfemoral).

Specific Criteria for Registry 1 (NR1) and Registry 4 (NR4)

Inclusion: Same criteria as Cohort B Including non-femoral access. Exclusion: Same criteria as Cohort B except exclusionary criteria #15 only excludes patients with renal insufficiency (creatinine >3.0 mg/dL).

Specific Criteria for Registry 2 (NR2)

Inclusion: Same criteria as Cohort B Including non-femoral access Exclusion: Same criteria as Cohort B, except for exclusion 22 which is modified for NR2 as follows:

• Iliofemoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath such as severe obstructive calcification, severe tortuosity or minimum average vessel size less than 6 mm and exclusionary criteria #15 only excludes patients with renal insufficiency (creatinine> 3.0 mg/dL).

Specific Criteria for Registry 3 (NR3)

Inclusion:

  1. Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
  2. NYHA class > II.
  3. Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.

Exclusion:

  1. Bioprosthetic valve labeled external diameter < 21mm.
  2. Surgical or transcatheter valve in another position on the same side of the heart (mitral and tricuspid rings are not an exclusion).
  3. Hemodynamic instability defined as requiring inotropic, pressor, or mechanical support.
  4. Infectious endocarditis within 6 months.
  5. Bacteremia within 1 month.
  6. Intra-cardiac thrombus or vegetation.
  7. Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  8. Percutaneous coronary intervention or implantation of a permanent pacemaker within 7 days of the index procedure.
  9. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (Plt < 50,000 cell/mL).
  10. Hypertrophic cardiomyopathy with obstruction (HOCM).
  11. Severe ventricular dysfunction with LVEF < 20%.
  12. Active upper GI bleeding within 3 months (90 days) prior to procedure requiring transfusion.
  13. Inability to be anticoagulated for the study procedure.
  14. Stroke or transient ischemic attack within 6 months (180 days).
  15. Insufficiency (creatinine > 3.0 mg/dL).
  16. Estimated life expectancy < 24 months.
  17. Participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  18. The patient requires emergency surgery for any reason.
  19. Xenograft or THV in another position.
  20. Index valve has moderate or severe paravalvular regurgitation.
  21. Index valve is unstable or rocking.
  22. Extensive, severe non-revascularized coronary disease.
  23. Increased risk of coronary obstruction by prosthetic leaflets (non-stented or internally stented valve which might extend above a coronary ostium).
  24. Increased risk of embolization (non-stented and non-calcified valve). Specific Criteria for Registry 5 (NR5) and Registry 6 (NR6) Inclusion: Same criteria as Cohort B including non-femoral access Exclusion: Same criteria as Cohort B except "Native aortic annulus size <18mm or >27mm as measured by echocardiogram and exclusionary criteria #15 only excludes patients with renal insufficiency (creatinine> 3.0 mg/dL).
  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: NCT01314313

Contacts
Contact: Becky Inderbitzen 949-250-6420 becky_inderbitzen@edwards.com

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Heart Hospital/Clinic Active, not recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Paul Teirstein, MD    858-554-9905    Teirstein.Paul@scrippshealth.org   
Contact: Scot Brewster, MD    (858) 455-6330    Brewster.Scot@scrippshealth.org   
Principal Investigator: Paul Teirstein, MD         
Principal Investigator: Scot Brewster, MD         
Scripps Memorial Hospital Active, not recruiting
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Rajendra Makkar, MD    310-423-3977    makkarr@cshs.org   
Contact: Alfredo Trento, MD    310-423-3977    trentoa@cshs.org   
Principal Investigator: Rajendra Makkar, MD         
Principal Investigator: Alfredo Trento, MD         
UC Davis Medical Center Active, not recruiting
Sacramento, California, United States, 95817
Mercy General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Kapil Sharma, MD    916-733-6850    Ksharma.md@gmail.com   
Contact: Michael Chang, MD    916-736-2333    Mchang5150@aol.com   
Principal Investigator: Kapil Sharma, MD         
Principal Investigator: Michael Chang, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: D. Craig Miller, MD    650-723-5771    dcm@stanford.edu   
Principal Investigator: D. Craig Miller, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: John Carroll, MD    720-848-6508    john.carroll@ucdenver.edu   
Contact: David Fullerton, MD    303-724-2798    david.fullerton@ucdenver.edu   
Principal Investigator: John Carroll, MD         
Principal Investigator: David Fullerton, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, DC, District of Columbia, United States, 20010
Contact: Augusto Pichard, MD    202-877-5975    guspichard@gmail.com   
Contact: Paul Corso, MD    202-877-7464    Paul.j.corso@medstar.net   
Principal Investigator: Augusto Pichard, MD         
Principal Investigator: Paul Corso, MD         
United States, Florida
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Joshua Rovin, MD    727-446-2273    jrovin@gmail.com   
Contact: Douglas Spriggs, MD    727-449-9257    douglasspriggs@gmail.com   
Principal Investigator: Joshua Rovin, MD         
Principal Investigator: Douglas Spriggs, MD         
University of Florida Recruiting
Gainesville, Florida, United States, 32615
Contact: Charles Klodell, MD    352-273-5501    Charles.klodell@surgery.ufl.edu   
Contact: R. David Anderson, MD       David.anderson@medicine.ufl.edu   
Principal Investigator: Charles Klodell, MD         
Principal Investigator: R. David Anderson, MD         
University of Miami Hospital Miller School of Medicine Active, not recruiting
Miami, Florida, United States, 33136
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vasilis Babaliaros, MD    404-712-0131    vbabaliaros@earthlink.net   
Contact: Vinod Thourani, MD    404-686-2513    vinod.thourani@emoryhealthcare.org   
Principal Investigator: Vasilis Babaliaros, MD         
Principal Investigator: Vinod Thourani, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: S. Chris Malaisrie, MD    312-695-2517    cmalaisr@nmh.org   
Principal Investigator: S. Chris Malaisrie, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Clifford Kavinsky, MD    312-942-4833    clifford_j_kavinsky@rush.edu   
Contact: Robert March, MD    (312) 942-6583    rmarch@rush.edu   
Principal Investigator: Clifford Kavinsky, MD         
Principal Investigator: Robert March, MD         
Northshore Recruiting
Evanston, Illinois, United States, 60201
Contact: Ted Feldman, MD    847-570-2250    tfeldman@enh.org   
Principal Investigator: Ted Feldman, MD         
Prairie Education and Research Cooperative Recruiting
Springfield, Illinois, United States, 62701
Contact: Gregory Mishkel, MD    217-788-0706    gmishkel@prairieheart.com   
Principal Investigator: Gregory Mishkel, MD         
United States, Indiana
Indiana University Health-Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anjan Sinha, MD    317-962-0561    sinhaa@iupui.edu   
Contact: Arthur Coffey, MD    317-923-1787    acoffey@iuhealth.org   
Principal Investigator: Anjan Sinha, MD         
Principal Investigator: Arthur Coffey, MD         
United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Phillip A Horwitz, MD    319-356-3689    phillip-horwitz@uiowa.edu   
Principal Investigator: Phillip A Horwitz, MD         
United States, Kentucky
The Jewish Hospital Medical Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Matthew Williams, MD    502-561-2180    mwilliams@louisvilleheartsurgery.com   
Contact: Mike Flaherty, MD    502-852-4379    mpflah01@louisville.edu   
Principal Investigator: Matthew Williams, MD         
Principal Investigator: Mike Flaherty, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Stephen R Ramee, MD    504-842-3727    sramee@aol.com   
Principal Investigator: Stephen R Ramee, MD         
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Bartley P Griffith, MD    410-328-3822    bgriffith@smail.umaryland.edu   
Principal Investigator: Bartley P Griffith, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frederick Welt, MD    857-307-1986    fwelt@partners.org   
Contact: Ralph Bolman, MD    617-732-6964    rbolman@partners.org   
Principal Investigator: Frederick Welt, MD         
Principal Investigator: Ralph Bolman, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Thoralf Sundt, MD    617-643-9745    tsundt@partners.org   
Principal Investigator: Thoralf Sundt, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Mayra Guerrero, MD    313-916-2381    mguerre1@hfhs.org   
Contact: Gaetano Paone, MD    313-916-2696    gpaone1@hfhs.org   
Principal Investigator: Mayra Guerrero, MD         
Principal Investigator: Gaetano Paone, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: George Hanzel, MD    248-898-4163    ghanzel@beaumont.edu   
Principal Investigator: George Hanzel, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Wesley Pederson, MD    612-863-3900    wesley.pedersen@allina.com   
Contact: Vibhu Kshettry, MD    612-863-6900    vibhu.kshettry@allina.com   
Principal Investigator: Wesley Pederson, MD         
Principal Investigator: Vibhu Kshettry, MD         
Mayo Clinic-Saint Marys Hospital Recruiting
Rochester, Minnesota, United States, 55905
Contact: Verghese Mathew, MD    800-471-1727    Mathew.verghese@mayo.edu   
Contact: Rakesh Suri, MD    800-471-1727    Suri.Rakesh@mayo.edu   
Principal Investigator: Verghese Mathew, MD         
Principal Investigator: Rakesh Suri, MD         
United States, Missouri
St. Luke's Hospital - Mid America Heart Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Michael Borkon, MD    816-931-3312    mborkon@aol.com   
Contact: Adnan Chhatriwalla, MD    816-931-1883    achhatriwalla@cc-pc.com   
Principal Investigator: Michael Borkon, MD         
Principal Investigator: Adnan Chhatriwalla, MD         
Washington University - Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Alan Zajarias, MD    314-454-8457    azajaria@dom.wustl.edu   
Contact: Hersh Maniar, MD    314-362-7431    maniarh@wustl.edu   
Principal Investigator: Alan Zajarias, MD         
Principal Investigator: Hersh Maniar, MD         
United States, Nebraska
Nebraska Heart Institute Recruiting
Lincoln, Nebraska, United States, 68526
Contact: James Wudel, MD    402-489-6555    jwudel@neheart.com   
Contact: Steve Martin, MD    402-489-6555    smartin@neheart.com   
Principal Investigator: James Wudel, MD         
Principal Investigator: Steve Martin, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: John F Robb, MD    603-650-5724    John.F.Robb@hitchcock.org   
Contact: Joseph P Desimone, MD    603-650-7390    Joseph.P.desimone@hitchcock.org   
Principal Investigator: John F Robb, MD         
Principal Investigator: Joseph P Desimone, MD         
United States, New Jersey
Cooper University Active, not recruiting
Camden, New Jersey, United States, 08103
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Marc Russo, MD    973-926-7905    mrusso@barnabashealth.org   
Contact: Marc Cohen, MD    973-926-7852    macohen@barnabashealth.org   
Principal Investigator: Marc Russo, MD         
Principal Investigator: Marc Cohen, MD         
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: John Goncalves, MD    516-663-4400    jgoncalves@winthrop.org   
Principal Investigator: John Goncalves, MD         
Northshore Long Island Jewish Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: S. Jacob Scheinerman, MD    718-470-7460    Sjschein@nshs.edu   
Principal Investigator: S. Jacob Scheinerman, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Susheel Kodali, MD    212-305-7060    sk2427@columbia.edu   
Contact: Mathew Williams, MD    (212) 305-8312    mw365@columbia.edu   
Principal Investigator: Susheel Kodali, MD         
Principal Investigator: Mathew Williams, MD         
New York Presbyterian Hospital - Cornell Recruiting
New York, New York, United States, 10021
Contact: S. Chiu Wong, MD    212-746-4644    scwong@med.cornell.edu   
Contact: Arash Salemi, MD    212-746-5873    ars9001@med.cornell.edu   
Principal Investigator: S. Chiu Wong, MD         
Principal Investigator: Arash Salemi, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27712
Contact: J. Kevin Harrison, MD    919-681-3763    John.harrison@duke.edu   
Contact: G. Chad Hughes, MD    919-668-0904    gchadhughes@duke.edu   
Principal Investigator: J. Kevin Harrison, MD         
Principal Investigator: G. Chad Hughes, MD         
East Carolina Heart Institute at East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Alan Kypson, MD    252-744-8482    kypsona@ecu.edu   
Contact: Ramesh Daggubati, MD    252-744-5287    daggubatir@ecu.edu   
Principal Investigator: Alan Kypson, MD         
Principal Investigator: Ramesh Daggubati, MD         
United States, Ohio
The Lindner Center for Research & Education at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dean J Kereiakes, MD    513-585-1777    lindnerMD@thechristhospital.com   
Contact: Thomas Ivey, MD    (513) 585-1777    grandindad@aol.com   
Principal Investigator: Dean J Kereiakes, MD         
Principal Investigator: Thomas Ivey, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: E. Murat Tuzcu, MD    216-444-8130    tuzcue@ccf.org   
Contact: Lars Svensson, MD    216-445-4813    svenssl@ccf.org   
Principal Investigator: E. Murat Tuzcu, MD         
Principal Investigator: Lars Svensson, MD         
United States, Oklahoma
Oklahoma Cardiovascular Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Mark Bodenhamer, MD    405-608-3800    mbodenhamer@okheart.com   
Contact: Mohammad Ghani, MD    405-608-3800    mghani@okheart.com   
Principal Investigator: Mark Bodenhamer, MD         
Principal Investigator: Mohammad Ghani, MD         
United States, Oregon
Providence Heart & Vascular Institute at Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Robert Hodson, MD    503-962-1000    robert.hodson@Rrovidence.org   
Contact: Jeff Swanson, MD    503-216-8670    Jeffrey.Swanson@providence.org   
Principal Investigator: Robert Hodson, MD         
Principal Investigator: Jeffrey Swanson, MD         
United States, Pennsylvania
University of Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph E Bavaria, MD    215-662-2017    joseph.bavaria@uphs.upenn.edu   
Contact: Howard Herrmann, MD    215-662-2180    howard.herrmann@uphs.upenn.edu   
Principal Investigator: Joseph E Bavaria, MD         
Principal Investigator: Howard Herrmann, MD         
York Hospital Recruiting
York, Pennsylvania, United States, 17403
Contact: William Nicholson, MD    717-851-2441    Wjnichmd2@aol.com   
Contact: Larry Shears, MD    717-851-6454    Ishears@wellspan.org   
Principal Investigator: William Nicholson, MD         
Principal Investigator: Larry Shears, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Daniel Steinberg, MD    843-876-4787    steinbe@musc.edu   
Contact: John Ikonomidis, MD    843-876-4842    ikonomij@musc.edu   
Principal Investigator: Daniel Steinberg, MD         
Principal Investigator: John Ikonomidis, MD         
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: H. Edward Garrett, Jr., MD    901-747-1262    egarrettmd@cvsclinic.com   
Contact: Basil M Paulus, MD    901-271-1000    basil.paulus@sterncardio.com   
Principal Investigator: H. Edwards Garrett, Jr., MD         
Principal Investigator: Basil M Paulus, MD         
United States, Texas
Austin Heart, PLLC Recruiting
Austin, Texas, United States, 78756
Contact: Frank J. Zidar, MD    843-876-4787    frank.zidar@hcahealthcare.com   
Contact: Faraz Kerendi, MD    843-876-4842    FKERENDI@ctvstexas.com   
Principal Investigator: Frank J. Zidar, MD         
Principal Investigator: Faraz Kerendi, MD         
Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Todd Dewey, MD    972-566-7219    todd.dewey@hcahealthcare.com   
Contact: Bruce Bowers, MD    972-566-7733    bruce.bowers@hcahealthcare.com   
Principal Investigator: Todd Dewey, MD         
Principal Investigator: Bruce Bowers, MD         
The Heart Hospital Baylor Plano Recruiting
Dallas, Texas, United States, 75093
Contact: William Brinkman, MD    469-800-6200    willibri@baylorhealth.edu   
Contact: David Brown, MD    972-566-7733    davidbro@baylorhealth.edu   
Principal Investigator: William Brinkman, MD         
Principal Investigator: David Brown, MD         
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Richard Smalling, MD, PhD    713-500-6559    richard.w.smalling@uth.tmc.edu   
Principal Investigator: Richard Smalling, MD, PhD         
University of Texas Health Science Center at San Antonio (UTHSCSA) Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Steven R Bailey, MD    210-567-4601    baileys@uthscsa.edu   
Contact: Andrea J Carpenter, MD    210-567-2878    Carpentera2@uthscsa.edu   
Principal Investigator: Steven R Bailey, MD         
Principal Investigator: Andrea J Carpenter, MD         
United States, Utah
IHC Health Services Inc. dba Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Brian Whisenant, MD    801-507-3500    Brian.Whisenant@imail.org   
Principal Investigator: Brian Whisenant, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: Irving Kron, MD    434-924-4270    ILK@hscmail.mcc.virginia.edu   
Principal Investigator: Irving Kron, MD         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Paul D Mahoney, MD    757-388-5480    pmahoney22@yahoo.com   
Contact: Jeffrey Rich, MD    757-388-5480    rich@macts.com   
Principal Investigator: Paul D Mahoney, MD         
Principal Investigator: Jeffrey Rich, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Larry Dean, MD    206-598-8257    lsdean@uw.edu   
Contact: Edward Verrier, MD    206-685-3370    edver@u.washington.edu   
Principal Investigator: Larry Dean, MD         
Principal Investigator: Edward Verrier, MD         
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Giogrio Gimelli, MD    608-263-0891    Email: gxg@medicine.wisc.edu   
Contact: Lucian Lozonschi, MD    608-262-3858    lozonschi@surgery.wisc.edu   
Principal Investigator: Giorgio Gimelli, MD         
Principal Investigator: Lucian Lozonschi, MD         
Canada, British Columbia
St. Paul's Hospital, Providence Health Care Active, not recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Active, not recruiting
Quebec, Canada, G1V465
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Martin B Leon, MD Columbia University
Principal Investigator: Craig Smith, MD Columbia University
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01314313     History of Changes
Other Study ID Numbers: 2010-12
Study First Received: March 7, 2011
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Edwards Lifesciences:
SAPIEN XT
SAPIEN 3
Transfemoral
Transapical
Transaortic
NovaFlex
TAVI
Aortic Stenosis
THV
Aortic Valve
Transcatheter Heart Valve
tAVR

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

ClinicalTrials.gov processed this record on September 18, 2014