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Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240902
First Posted: November 15, 2010
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular
  Purpose
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medtronic CoreValve® U.S. Pivotal Trial

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality [ Time Frame: 1 year ]
    All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)


Secondary Outcome Measures:
  • Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    MACCE is defined as a composite of:

    • All Cause Mortality
    • Myocardial infarction (MI)
    • All Stroke
    • 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: 30 day, 6 month, 1 year, 2 year ]

    Individual MACCE Components Include:

    • All Cause Mortality
    • MI
    • All stroke
    • Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

  • Major Adverse Events (MAEs) [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    MAEs Include:

    • MACCE
    • Acute Kidney Injury
    • Cardiac Tamponade
    • Prosthetic Valve Dysfunction
    • Cardiogenic Shock
    • Valve Endocarditis
    • Life-Threatening, Disabling or Major Bleeding
    • Major Vascular Complication
    • Cardiac Perforation
    • Device Migration/Valve Embolism

  • Conduction Disturbance Requiring Permanent Pacemaker Implantation [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  • Change in NYHA Class [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.

    New York Heart Association (NYHA) Classification:

    Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

    Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

    Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

    Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.


  • Change in Distance Walked During 6-Minute Walk Test (6MWT) [ Time Frame: 30 day, 1 year ]
    Change in distance walked during 6MWT from baseline

  • Ratio of Days Alive Out of Hospital Versus Total Days Alive [ Time Frame: 1 year ]
  • Quality of Life (QoL) Change [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    QoL summary score change from baseline using the following measures:

    • Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
    • 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
    • European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.

  • Echocardiographic Assessment of Valve Performance [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    Using the following measures:

    - Effective Orifice Area (EOA)


  • Echocardiographic Assessment of Valve Performance [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    Using the following measures:

    - Transvalvular Mean Gradient


  • Echocardiographic Assessment of Valve Performance [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    Using the following measure:

    - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)


  • Aortic Valve Hospitalizations [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  • Cardiovascular Deaths and Valve Related Deaths [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
  • Strokes and Transient Ischemic Attacks (TIAs) [ Time Frame: 30 day, 6 month, 1 year, 2 year ]
    Strokes (of any severity) and TIAs

  • Index Procedure Related MAEs [ Time Frame: Procedure ]
  • Length of Index Procedure Hospital Stay [ Time Frame: Number of days from admission to discharge ]
  • Device Success [ Time Frame: Number of days from admission to discharge ]

    Medtronic CoreValve® System subjects only.

    Defined as:

    • Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
    • Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
    • Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)
    • Only one valve implanted in the proper anatomical location

  • Procedural Success [ Time Frame: Number of days from admission to discharge ]

    Medtronic CoreValve® System subjects only.

    Defined as device success and absence of in-hospital MACCE.


  • Prosthetic Valve Dysfunction (PVD) [ Time Frame: 30 day, 6 month, 1 year, 2 year ]

    PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:

    • Peak velocity >4 m/s
    • Mean gradient >35 mmHg
    • EOA < 0.8 cm2
    • TVIV1 / TVIV2 < 0.25


Enrollment: 1453
Study Start Date: November 2010
Estimated Study Completion Date: August 2020
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extreme Risk: TAVI Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Experimental: Extreme Risk: TAVI Non-Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Experimental: High Risk: TAVI
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: High Risk: SAVR
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
Device: Surgical Aortic Valve Replacement (SAVR)
Surgical Aortic Valve Replacement (SAVR)

  Eligibility

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, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
  • High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of < 50%) at 30 days.
  • Subject has senile degenerative aortic valve stenosis with: mean gradient > 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
  • Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
  • The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site.
  • The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

Clinical

  • Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.)
  • Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  • Need for emergency surgery for any reason.
  • Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram.
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  • End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min.
  • Active Gastrointestinal (GI) bleeding within the past 3 months.
  • A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
  • Aspirin
  • Heparin (HIT/HITTS)
  • Bivalirudin (Extreme Risk Only)
  • Nitinol (titanium or nickel)
  • Ticlopidine and clopidogrel
  • Contrast media
  • Ongoing sepsis, including active endocarditis.
  • Subject refuses a blood transfusion.
  • Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
  • Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
  • 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).
  • Currently participating in an investigational drug or another device trial.
  • Symptomatic carotid or vertebral artery disease.
  • Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only)

Anatomical

  • Native aortic annulus size < 18 mm or > 29 mm per the baseline diagnostic imaging.
  • Pre-existing prosthetic heart valve any position.
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).
  • Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.
  • Moderate to severe mitral stenosis.
  • Hypertrophic obstructive cardiomyopathy.
  • New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Severe basal septal hypertrophy with an outflow gradient.
  • Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30° (for right subclavian/axillary access).
  • Ascending aorta diameter > 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter > 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter > 34 mm if the aortic annulus diameter is 18-20 mm.
  • Congenital bicuspid or unicuspid valve verified by echocardiography.
  • Sinus of valsalva anatomy that would prevent adequate coronary perfusion.

Vascular

- Transarterial access not able to accommodate an 18Fr sheath.

  Contacts and Locations
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): NCT01240902


  Show 45 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: David H Adams, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Jeffrey J Popma, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Kleiman NS, Maini BJ, Reardon MJ, Conte J, Katz S, Rajagopal V, Kauten J, Hartman A, McKay R, Hagberg R, Huang J, Popma J; CoreValve Investigators. Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials. Circ Cardiovasc Interv. 2016 Sep;9(9). pii: e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.
Reardon MJ, Kleiman NS, Adams DH, Yakubov SJ, Coselli JS, Deeb GM, O'Hair D, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Huang J, Popma JJ. Outcomes in the Randomized CoreValve US Pivotal High Risk Trial in Patients With a Society of Thoracic Surgeons Risk Score of 7% or Less. JAMA Cardiol. 2016 Nov 1;1(8):945-949. doi: 10.1001/jamacardio.2016.2257.
Popma JJ, Reardon MJ, Yakubov SJ, Hermiller JB Jr, Harrison JK, Gleason TG, Conte JV, Deeb GM, Chetcuti S, Oh JK, Boulware MJ, Huang J, Adams DH; CoreValve US Clinical Investigators. Safety and Efficacy of Self-Expanding TAVR in Patients With Aortoventricular Angulation. JACC Cardiovasc Imaging. 2016 Aug;9(8):973-81. doi: 10.1016/j.jcmg.2016.06.002.
Hermiller JB Jr, Yakubov SJ, Reardon MJ, Deeb GM, Adams DH, Afilalo J, Huang J, Popma JJ; CoreValve United States Clinical Investigators. Predicting Early and Late Mortality After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jul 26;68(4):343-52. doi: 10.1016/j.jacc.2016.04.057.
Popma JJ, Gleason TG, Yakubov SJ, Harrison JK, Forrest JK, Maini B, Ruiz CE, Pinto DS, Costa M, Resar J, Conte J, Crestanello J, Chang Y, Oh JK, Reardon MJ, Adams DH. Relationship of Annular Sizing Using Multidetector Computed Tomographic Imaging and Clinical Outcomes After Self-Expanding CoreValve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2016 Jul;9(7). pii: e003282. doi: 10.1161/CIRCINTERVENTIONS.115.003282.
Little SH, Oh JK, Gillam L, Sengupta PP, Orsinelli DA, Cavalcante JL, Chang JD, Adams DH, Zorn GL 3rd, Pollak AW, Abdelmoneim SS, Reardon MJ, Qiao H, Popma JJ. Self-Expanding Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Patients at High Risk for Surgery: A Study of Echocardiographic Change and Risk Prediction. Circ Cardiovasc Interv. 2016 Jun;9(6). pii: e003426. doi: 10.1161/CIRCINTERVENTIONS.115.003426.
Dauerman HL, Reardon MJ, Popma JJ, Little SH, Cavalcante JL, Adams DH, Kleiman NS, Oh JK. Early Recovery of Left Ventricular Systolic Function After CoreValve Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2016 Jun;9(6). pii: e003425. doi: 10.1161/CIRCINTERVENTIONS.115.003425.
Deeb GM, Reardon MJ, Chetcuti S, Patel HJ, Grossman PM, Yakubov SJ, Kleiman NS, Coselli JS, Gleason TG, Lee JS, Hermiller JB Jr, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte J, Resar J, Aharonian V, Pfeffer T, Oh JK, Qiao H, Adams DH, Popma JJ; CoreValve US Clinical Investigators. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jun 7;67(22):2565-74. doi: 10.1016/j.jacc.2016.03.506. Epub 2016 Apr 3.
Reynolds MR, Lei Y, Wang K, Chinnakondepalli K, Vilain KA, Magnuson EA, Galper BZ, Meduri CU, Arnold SV, Baron SJ, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve US High Risk Pivotal Trial Investigators. Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self-Expanding Prosthesis Versus Surgical Aortic Valve Replacement. J Am Coll Cardiol. 2016 Jan 5;67(1):29-38. doi: 10.1016/j.jacc.2015.10.046.
Oh JK, Little SH, Abdelmoneim SS, Reardon MJ, Kleiman NS, Lin G, Bach D, Gillam L, Kar B, Coselli J, Sengupta PP, Grewal K, Chang J, Chang Y, Boulware M, Adams DH, Popma JJ; CoreValve U.S. Pivotal Trial Clinical Investigators. Regression of Paravalvular Aortic Regurgitation and Remodeling of Self-Expanding Transcatheter Aortic Valve: An Observation From the CoreValve U.S. Pivotal Trial. JACC Cardiovasc Imaging. 2015 Dec;8(12):1364-1375. doi: 10.1016/j.jcmg.2015.07.012. Epub 2015 Oct 26.
Yakubov SJ, Adams DH, Watson DR, Reardon MJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Schreiber T, Gleason TG, Conte J, Deeb GM, Huang J, Oh J, Byrne T, Caskey M, Popma JJ; CoreValve United States Clinical Investigators. 2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery. J Am Coll Cardiol. 2015 Sep 22;66(12):1327-34. doi: 10.1016/j.jacc.2015.07.042.
Arnold SV, Reynolds MR, Wang K, Magnuson EA, Baron SJ, Chinnakondepalli KM, Reardon MJ, Tadros PN, Zorn GL, Maini B, Mumtaz MA, Brown JM, Kipperman RM, Adams DH, Popma JJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Health Status After Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Increased Surgical Risk: Results From the CoreValve US Pivotal Trial. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1207-1217. doi: 10.1016/j.jcin.2015.04.018.
Reardon MJ, Adams DH, Kleiman NS, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Lee JS, Hermiller JB Jr, Chetcuti S, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Maini B, Mumtaz M, Conte JV, Resar JR, Aharonian V, Pfeffer T, Oh JK, Qiao H, Popma JJ. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2015 Jul 14;66(2):113-21. doi: 10.1016/j.jacc.2015.05.017. Epub 2015 Jun 5.
Osnabrugge RL, Arnold SV, Reynolds MR, Magnuson EA, Wang K, Gaudiani VA, Stoler RC, Burdon TA, Kleiman N, Reardon MJ, Adams DH, Popma JJ, Cohen DJ; CoreValve U.S. Trial Investigators. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. JACC Cardiovasc Interv. 2015 Feb;8(2):315-323. doi: 10.1016/j.jcin.2014.08.016.
Reardon MJ, Adams DH, Coselli JS, Deeb GM, Kleiman NS, Chetcuti S, Yakubov SJ, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Khabbaz K, Tadros P, Zorn GL 3rd, Merhi W, Heiser J, Petrossian G, Robinson N, Maini B, Mumtaz M, Lee JS, Gleason TG, Resar J, Conte J, Watson D, Chenoweth S, Popma JJ; CoreValve US Clinical Investigators. Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery. J Thorac Cardiovasc Surg. 2014 Dec;148(6):2869-76.e1-7. doi: 10.1016/j.jtcvs.2014.07.020. Epub 2014 Jul 30.
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, Hermiller J Jr, Hughes GC, Harrison JK, Coselli J, Diez J, Kafi A, Schreiber T, Gleason TG, Conte J, Buchbinder M, Deeb GM, Carabello B, Serruys PW, Chenoweth S, Oh JK; CoreValve United States Clinical Investigators. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014 May 20;63(19):1972-81. doi: 10.1016/j.jacc.2014.02.556. Epub 2014 Mar 19.

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01240902     History of Changes
Other Study ID Numbers: MCV-US-2009-01
First Submitted: November 10, 2010
First Posted: November 15, 2010
Results First Submitted: March 6, 2015
Results First Posted: June 8, 2015
Last Update Posted: May 23, 2017
Last Verified: April 2017

Keywords provided by Medtronic Cardiovascular:
Valvular Heart Disease
Critical Aortic Stenosis
Severe Aortic Stenosis
High Risk
Aortic Valve Replacement

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction


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