Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
NCT ID: NCT01586910
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
1746 participants
INTERVENTIONAL
2012-04-30
2026-11-30
Brief Summary
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Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medtronic CoreValve® System TAVI
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
SAVR
Surgical Aortic Valve Replacement (SAVR)
Surgical Aortic Valve Replacement (SAVR)
Interventions
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Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Surgical Aortic Valve Replacement (SAVR)
Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Eligibility Criteria
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Inclusion Criteria
* Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
* Subject has severe aortic stenosis presenting with;
1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25;
* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;
Exclusion Criteria
* Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
* A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
* Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
* Ongoing sepsis, including active endocarditis;
* Any condition considered a contraindication to extracorporeal assistance;
* Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
* Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*;
* Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
* Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
* Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
* Subject refuses a blood transfusion;
* 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);
* Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
* Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
* Currently participating in an investigational drug or another device trial (excluding registries);
* Evidence of an acute myocardial infarction ≤30 days before the index procedure;
* Need for emergency surgery for any reason;
* True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
* Extensive mediastinal radiation;
* Liver failure (Child-C);
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram;
* Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm);
* Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
* End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min;
* Pulmonary Hypertension (systolic pressure\> 80mmHg);
* Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc;
* Frailty assessments identify:
1. Subject is \< 80 years of age and three or more of the following apply
2. Subject is ≥ 80 years of age and two or more of the following apply
* Wheelchair bound
* Resides in an institutional care facility (e.g., nursing home, skilled care center)
* Body Mass Index \< 20 kg/m2
* Grip Strength \< 16 kg
* Katz Index Score ≤ 4
* Albumin \< 3.5 g/dL;
* Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)
Note: \* For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Windecker, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital
Rüdiger Lange, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum München
Thomas Walther, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff Klinik
Michael J. Reardon, MD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
David H. Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Nicolas M. Van Mieghem, MD
Role: STUDY_CHAIR
Erasmus Medical Center
Patrick W. Serruys, MD, PhD
Role: STUDY_CHAIR
National Heart & Lung Institute of Imperial College in London
Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Hollywood, California, United States
Scripps Green Hospital
La Jolla, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Southern California Permenente Medical Group
Pasadena, California, United States
Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Miami
Coral Gables, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Loyola University of Chicago
Maywood, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Iowa Heart Center / Mercy Medical Center
West Des Moines, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Detroit Medical Center
Detroit, Michigan, United States
Henry Ford
Detroit, Michigan, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Abbott NW - MN Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota, United States
Saint Luke's Hospital/MAHI
Kansas City, Missouri, United States
Alegent Creighton Health Research Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
New York University School of Medicine
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Carolinas HealthCare System
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
The OhioHealth Research Institute
Columbus, Ohio, United States
Oklahoma Heart Institute
Oklahoma City, Oklahoma, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Stern Cardiovascular
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
The Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States
The Heart Hospital - Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Vermont
Burlington, Vermont, United States
Sentara Cardiovascular
Norfolk, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada
McGill University Health Center - Royal Victoria Hospital
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, , Canada
Rigshospitalet
Copenhagen, , Denmark
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Deutsches Herzzentrum Muenchen
Munich, , Germany
Amphia Hospital Breda
Breda, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
St. Antonius Hospital, R & D Cardiology
Nieuwegein, , Netherlands
Erasmus Medical Center - Rotterdam
Rotterdam, , Netherlands
Servicio de Cardiologia del Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Karolinska Universitetssjukhuset Stockholm
Stockholm, , Sweden
Bern University Hospital
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Leeds General Infirmary
Leeds, , United Kingdom
Glenfield Hospital, Leicester, UK
Leicester, , United Kingdom
St. George's Hospital London
London, , United Kingdom
Countries
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References
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Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
Kleiman NS, Van Mieghem NM, Reardon MJ, Gada H, Mumtaz M, Olsen PS, Heiser J, Merhi W, Chetcuti S, Deeb GM, Chawla A, Kiaii B, Teefy P, Chu MWA, Yakubov SJ, Windecker S, Althouse AD, Baron SJ. Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients. JACC Cardiovasc Interv. 2024 Apr 22;17(8):979-988. doi: 10.1016/j.jcin.2024.02.014.
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.
Tuttle MK, Kiaii B, Van Mieghem NM, Laham RJ, Deeb GM, Windecker S, Chetcuti S, Yakubov SJ, Chawla A, Hockmuth D, Teefy P, Li S, Reardon MJ. Functional Status After Transcatheter and Surgical Aortic Valve Replacement: 2-Year Analysis From the SURTAVI Trial. JACC Cardiovasc Interv. 2022 Apr 11;15(7):728-738. doi: 10.1016/j.jcin.2022.01.284.
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.
Mumtaz M, Wyler von Ballmoos MC, Deeb GM, Popma JJ, Van Mieghem NM, Kleiman NS, Gleason TG, Chawla A, Hockmuth D, Zorn GL 3rd, Tadros P, Li S, Reardon MJ. The Impact of Transfusions on Mortality After Transcatheter or Surgical Aortic Valve Replacement. Ann Thorac Surg. 2021 Sep;112(3):778-785. doi: 10.1016/j.athoracsur.2020.09.031. Epub 2020 Nov 17.
Attizzani GF, Dallan LAP, Markowitz A, Yakubov SJ, Deeb GM, Reardon MJ, Forrest JK, Mangi AA, Huang J, Popma JJ. Impact of Repositioning on Outcomes Following Transcatheter Aortic Valve Replacement With a Self-Expandable Valve. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1816-1824. doi: 10.1016/j.jcin.2020.04.028.
Yakubov SJ, Van Mieghem NM, Reardon MJ, Serruys PW, Gada H, Mumtaz M, Deeb GM, Kodali S, George I, Windecker S, Kleiman N, Chetcuti SJ, Sanchez C, Dauerman HL, Li S, Popma JJ. Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial). Am J Cardiol. 2020 Sep 15;131:82-90. doi: 10.1016/j.amjcard.2020.06.051. Epub 2020 Jun 29.
Van Mieghem NM, Reardon MJ, Yakubov SJ, Heiser J, Merhi W, Windecker S, Makkar RR, Cheng W, Robbins M, Fail P, Feinberg E 2nd, Stoler RC, Hebeler R, Serruys PW, Popma JJ. Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial. EuroIntervention. 2020 Nov 20;16(10):833-841. doi: 10.4244/EIJ-D-20-00303.
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.
Sondergaard L, Popma JJ, Reardon MJ, Van Mieghem NM, Deeb GM, Kodali S, George I, Williams MR, Yakubov SJ, Kappetein AP, Serruys PW, Grube E, Schiltgen MB, Chang Y, Engstrom T. Comparison of a Complete Percutaneous Versus Surgical Approach to Aortic Valve Replacement and Revascularization in Patients at Intermediate Surgical Risk: Results From the Randomized SURTAVI Trial. Circulation. 2019 Oct 15;140(16):1296-1305. doi: 10.1161/CIRCULATIONAHA.118.039564. Epub 2019 Sep 3.
Reardon MJ, Heijmen RH, Van Mieghem NM, Williams MR, Yakubov SJ, Watson D, Kleiman NS, Conte J, Chawla A, Hockmuth D, Petrossian G, Robinson N, Kappetein AP, Li S, Popma JJ. Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial. JAMA Cardiol. 2019 Aug 1;4(8):810-814. doi: 10.1001/jamacardio.2019.1856.
Head SJ, Reardon MJ, Deeb GM, Van Mieghem NM, Popma JJ, Gleason TG, Williams MR, Radhakrishnan S, Fremes S, Oh JK, Chang Y, Boulware MJ, Kappetein AP. Computed Tomography-Based Indexed Aortic Annulus Size to Predict Prosthesis-Patient Mismatch. Circ Cardiovasc Interv. 2019 Apr;12(4):e007396. doi: 10.1161/CIRCINTERVENTIONS.118.007396.
Durko AP, Reardon MJ, Kleiman NS, Popma JJ, Van Mieghem NM, Gleason TG, Bajwa T, O'Hair D, Brown DL, Ryan WH, Chang Y, De Leon SD, Kappetein AP. Neurological Complications After Transcatheter Versus Surgical Aortic Valve Replacement in Intermediate-Risk Patients. J Am Coll Cardiol. 2018 Oct 30;72(18):2109-2119. doi: 10.1016/j.jacc.2018.07.093.
Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.
Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015 Sep;11 Suppl W:W86-91. doi: 10.4244/EIJV11SWA27.
Piazza N, Kalesan B, van Mieghem N, Head S, Wenaweser P, Carrel TP, Bleiziffer S, de Jaegere PP, Gahl B, Anderson RH, Kappetein AP, Lange R, Serruys PW, Windecker S, Juni P. A 3-center comparison of 1-year mortality outcomes between transcatheter aortic valve implantation and surgical aortic valve replacement on the basis of propensity score matching among intermediate-risk surgical patients. JACC Cardiovasc Interv. 2013 May;6(5):443-51. doi: 10.1016/j.jcin.2013.01.136.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IDE #G120169
Identifier Type: -
Identifier Source: org_study_id
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