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

NCT01240902 | Completed Results DMC

• 1 other identifier: MCV-US-2009-01
• Study Type: interventional
• Target: 1,453
• Locations: 1 country
• Sites: 45

Brief Summary

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.

Conditions

Severe Aortic Stenosis

Keywords

Valvular Heart Disease; Critical Aortic Stenosis; Severe Aortic Stenosis; High Risk; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality

  All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)

  1 year

Secondary Outcomes (19)

• Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)

  30 day, 6 month, 1 year, 2 year

• The Occurrence of Individual MACCE Components

  30 day, 6 month, 1 year, 2 year

• Major Adverse Events (MAEs)

  30 day, 6 month, 1 year, 2 year

• Conduction Disturbance Requiring Permanent Pacemaker Implantation

  30 day, 6 month, 1 year, 2 year

• Change in NYHA Class

  30 day, 6 month, 1 year, 2 year

Study Arms (4)

Extreme Risk: TAVI Iliofemoral

EXPERIMENTAL

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Extreme Risk: TAVI Non-Iliofemoral

EXPERIMENTAL

Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

High Risk: TAVI

EXPERIMENTAL

High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

High Risk: SAVR

ACTIVE COMPARATOR

High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)

Device: Surgical Aortic Valve Replacement (SAVR)

Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) DEVICE

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Extreme Risk: TAVI Iliofemoral; Extreme Risk: TAVI Non-Iliofemoral; High Risk: TAVI

Surgical Aortic Valve Replacement (SAVR) DEVICE

Surgical Aortic Valve Replacement (SAVR)

High Risk: SAVR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (45)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

University of Southern California University Hospital

Los Angeles, California, 90033, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Washington Hospital Center / Georgetown Hospital

Washington D.C., District of Columbia, 20010, United States

Location

University of Miami Health System / Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Institute of the South/ Terrebone General

Houma, Louisiana, 70360, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Detroit Medical Center Cardiovascular Institute

Detroit, Michigan, 48201, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

North Shore University Hospital/ Long Island Jewish Hospital

Manhasset, New York, 11030, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University - Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals - Case Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Medical Center - The Richard M. Ross Heart Hospital

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17043, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Texas Heart Institute at St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05458, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

St. Luke's Medical Center - Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (27)

• O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627.

  PMID: 36515976 DERIVED

• Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.

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• Arnold SV, Petrossian G, Reardon MJ, Kleiman NS, Yakubov SJ, Wang K, Hermiller J Jr, Harrison JK, Deeb GM, Huang J, Cohen DJ; US CoreValve Investigators. Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial. Circ Cardiovasc Interv. 2021 Jun;14(6):e010258. doi: 10.1161/CIRCINTERVENTIONS.120.010258. Epub 2021 Jun 7.

  PMID: 34092091 DERIVED

• Arnold SV, Chinnakondepalli KM, Magnuson EA, Reardon MJ, Deeb GM, Gleason T, Yakubov SJ, Cohen DJ; CoreValve US Pivotal Trial Investigators. Five-Year Health Status After Self-expanding Transcatheter or Surgical Aortic Valve Replacement in High-risk Patients With Severe Aortic Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):97-101. doi: 10.1001/jamacardio.2020.4397.

  PMID: 32997095 DERIVED

• Ito S, Nkomo VT, Orsinelli DA, Lin G, Cavalcante J, Popma JJ, Adams DH, Checuti SJ, Deeb GM, Boulware M, Huang J, Little SH, Cohen SA, Reardon MJ, Oh JK. Impact of Stroke Volume Index and Left Ventricular Ejection Fraction on Mortality After Aortic Valve Replacement. Mayo Clin Proc. 2020 Jan;95(1):69-76. doi: 10.1016/j.mayocp.2019.10.031.

  PMID: 31902431 DERIVED

• Lindman BR, Goel K, Bermejo J, Beckman J, O'Leary J, Barker CM, Kaiser C, Cavalcante JL, Elmariah S, Huang J, Hickey GL, Adams DH, Popma JJ, Reardon MJ. Lower Blood Pressure After Transcatheter or Surgical Aortic Valve Replacement is Associated with Increased Mortality. J Am Heart Assoc. 2019 Nov 5;8(21):e014020. doi: 10.1161/JAHA.119.014020. Epub 2019 Oct 31.

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• Pineda AM, Kevin Harrison J, Kleiman NS, Reardon MJ, Conte JV, O'Hair DP, Chetcuti SJ, Huang J, Yakubov SJ, Popma JJ, Beohar N. Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):740-748. doi: 10.1002/ccd.27928. Epub 2018 Oct 20.

  PMID: 30341970 DERIVED

• Gleason TG, Reardon MJ, Popma JJ, Deeb GM, Yakubov SJ, Lee JS, Kleiman NS, Chetcuti S, Hermiller JB Jr, Heiser J, Merhi W, Zorn GL 3rd, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte JV, Mumtaz M, Oh JK, Huang J, Adams DH; CoreValve U.S. Pivotal High Risk Trial Clinical Investigators. 5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients. J Am Coll Cardiol. 2018 Dec 4;72(22):2687-2696. doi: 10.1016/j.jacc.2018.08.2146. Epub 2018 Sep 21.

  PMID: 30249462 DERIVED

• Grayburn PA, Oh JK, Reardon MJ, Popma JJ, Deeb GM, Boulware M, Huang J, Stoler RC. Effect of Baseline Aortic Regurgitation on Mortality in Patients Treated With Transcatheter or Surgical Aortic Valve Replacement (from the CoreValve US Pivotal Trial). Am J Cardiol. 2018 Nov 1;122(9):1527-1535. doi: 10.1016/j.amjcard.2018.07.018. Epub 2018 Aug 3.

  PMID: 30172363 DERIVED

• Crestanello JA, Popma JJ, Adams DH, Deeb GM, Mumtaz M, George B, Huang J, Reardon MJ. Long-Term Health Benefit of Transcatheter Aortic Valve Replacement in Patients With Chronic Lung Disease. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2283-2293. doi: 10.1016/j.jcin.2017.07.025. Epub 2017 Nov 1.

  PMID: 29102579 DERIVED

• 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):e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.

  PMID: 27601429 DERIVED

• 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.

  PMID: 27541162 DERIVED

• 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.

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• 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):e003282. doi: 10.1161/CIRCINTERVENTIONS.115.003282.

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• 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):e003426. doi: 10.1161/CIRCINTERVENTIONS.115.003426.

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• 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):e003425. doi: 10.1161/CIRCINTERVENTIONS.115.003425.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 26055947 DERIVED

• 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.

  PMID: 25700755 DERIVED

• 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.

  PMID: 25152474 DERIVED

• 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.

  PMID: 24678937 DERIVED

• 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.

  PMID: 24657695 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Hatice Bilgic Lim
• Organization: Medtronic, Inc.

rs.medtroniccardiovascularclinicaltrials@medtronic.com

Study Officials

• David H Adams, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 15, 2010
• Study Start: December 10, 2010
• Primary Completion: August 1, 2014
• Study Completion: May 15, 2019
• Last Updated: October 25, 2022
• Results First Posted: June 8, 2015

Record last verified: 2022-10

Locations

US (45)