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
NCT ID: NCT01240902
Last Updated: 2022-10-25
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1453 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-12-10
Study Completion Date
2019-05-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Severe Aortic Stenosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Extreme Risk: TAVI Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Group Type
EXPERIMENTAL
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Intervention Type
DEVICE
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Extreme Risk: TAVI Non-Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Group Type
EXPERIMENTAL
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Intervention Type
DEVICE
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: TAVI
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Group Type
EXPERIMENTAL
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Intervention Type
DEVICE
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: SAVR
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
Group Type
ACTIVE_COMPARATOR
Surgical Aortic Valve Replacement (SAVR)
Intervention Type
DEVICE
Surgical Aortic Valve Replacement (SAVR)
Interventions
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Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Intervention Type
DEVICE
Surgical Aortic Valve Replacement (SAVR)
Surgical Aortic Valve Replacement (SAVR)
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
* 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.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David H Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Banner Good Samaritan
Phoenix, Arizona, United States
Site Status
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
Site Status
University of Southern California University Hospital
Los Angeles, California, United States
Site Status
El Camino Hospital
Mountain View, California, United States
Site Status
VA Palo Alto Health Care System
Palo Alto, California, United States
Site Status
Hartford Hospital
Hartford, Connecticut, United States
Site Status
Yale New Haven Hospital
New Haven, Connecticut, United States
Site Status
Washington Hospital Center / Georgetown Hospital
Washington D.C., District of Columbia, United States
Site Status
University of Miami Health System / Jackson Memorial Hospital
Miami, Florida, United States
Site Status
Mount Sinai Medical Center
Miami Beach, Florida, United States
Site Status
Piedmont Heart Institute
Atlanta, Georgia, United States
Site Status
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Site Status
Loyola University Medical Center
Maywood, Illinois, United States
Site Status
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Site Status
Iowa Heart Center
Des Moines, Iowa, United States
Site Status
University of Kansas Hospital
Kansas City, Kansas, United States
Site Status
Cardiovascular Institute of the South/ Terrebone General
Houma, Louisiana, United States
Site Status
Johns Hopkins Hospital
Baltimore, Maryland, United States
Site Status
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Site Status
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Site Status
Detroit Medical Center Cardiovascular Institute
Detroit, Michigan, United States
Site Status
St. John Hospital and Medical Center
Detroit, Michigan, United States
Site Status
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Site Status
Morristown Memorial Hospital
Morristown, New Jersey, United States
Site Status
North Shore University Hospital/ Long Island Jewish Hospital
Manhasset, New York, United States
Site Status
NYU Langone Medical Center
New York, New York, United States
Site Status
The Mount Sinai Medical Center
New York, New York, United States
Site Status
Lenox Hill Hospital
New York, New York, United States
Site Status
St. Francis Hospital
Roslyn, New York, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina, United States
Site Status
University Hospitals - Case Medical Center
Cleveland, Ohio, United States
Site Status
The Ohio State University Medical Center - The Richard M. Ross Heart Hospital
Columbus, Ohio, United States
Site Status
Riverside Methodist Hospital
Columbus, Ohio, United States
Site Status
Geisinger Medical Center
Danville, Pennsylvania, United States
Site Status
Pinnacle Health
Harrisburg, Pennsylvania, United States
Site Status
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Site Status
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Site Status
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Site Status
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
Site Status
The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States
Site Status
University of Vermont Medical Center
Burlington, Vermont, United States
Site Status
Inova Fairfax Hospital
Falls Church, Virginia, United States
Site Status
Providence Sacred Heart Medical Center
Spokane, Washington, United States
Site Status
St. Luke's Medical Center - Aurora Health Care
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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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.
Reference Type
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.
Reference Type
DERIVED
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCV-US-2009-01
Identifier Type: -
Identifier Source: org_study_id
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