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).
SURTAVI
Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)
1 other identifier
interventional
1,746
9 countries
86
Brief Summary
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 24, 2012
CompletedFirst Posted
Study publicly available on registry
April 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedResults Posted
Study results publicly available
September 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedOctober 28, 2025
October 1, 2025
6.3 years
April 24, 2012
July 17, 2019
October 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
24 months
Secondary Outcomes (25)
Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Individual MACCE Components
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Major Adverse Events (MAE)
30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Change in NYHA Class From Baseline
Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
- +20 more secondary outcomes
Study Arms (2)
Medtronic CoreValve® System TAVI
EXPERIMENTALMedtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
SAVR
ACTIVE COMPARATORSurgical Aortic Valve Replacement (SAVR)
Interventions
Eligibility Criteria
You may qualify if:
- Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
- 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;
- Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND
- 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;
You may not qualify if:
- Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
- 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;
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Cedars-Sinai Medical Center
Hollywood, California, 90048, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
El Camino Hospital
Mountain View, California, 94040, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Southern California Permenente Medical Group
Pasadena, California, 91101, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale New Haven Hospital
New Haven, Connecticut, 06520-8047, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
University of Miami
Coral Gables, Florida, 33146, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Emory University
Atlanta, Georgia, 30308, United States
Piedmont Healthcare, Inc.
Atlanta, Georgia, 30309, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Loyola University of Chicago
Maywood, Illinois, 60153, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Iowa Heart Center / Mercy Medical Center
West Des Moines, Iowa, 50266, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
The Johns Hopkins University
Baltimore, Maryland, 21205, United States
Beth Israel Deaconess Medical Center, Inc.
Boston, Massachusetts, 02215, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109-5864, United States
Detroit Medical Center
Detroit, Michigan, 48201-2018, United States
Henry Ford
Detroit, Michigan, 48202, United States
St. John Hospital & Medical Center
Detroit, Michigan, 48236, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, 49503, United States
Abbott NW - MN Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota, 55905, United States
Saint Luke's Hospital/MAHI
Kansas City, Missouri, 64111, United States
Alegent Creighton Health Research Center
Omaha, Nebraska, 68124, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
New York University School of Medicine
New York, New York, 10016, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Lenox Hill Hospital
New York, New York, 10075, United States
University of Rochester
Rochester, New York, 14642, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
The OhioHealth Research Institute
Columbus, Ohio, 43214, United States
Oklahoma Heart Institute
Oklahoma City, Oklahoma, 73120, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043, United States
Stern Cardiovascular
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
The Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
The Heart Hospital - Baylor Plano
Plano, Texas, 75093, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Vermont
Burlington, Vermont, 05401, United States
Sentara Cardiovascular
Norfolk, Virginia, 23507, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Toronto General Hospital (University Health Network)
Toronto, Ontario, M5G 2C4, Canada
McGill University Health Center - Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal Heart Institute
Montreal, Canada
Rigshospitalet
Copenhagen, Denmark
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Bad Krozingen, 79106, 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, 171 76, Sweden
Bern University Hospital
Bern, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Leeds General Infirmary
Leeds, United Kingdom
Glenfield Hospital, Leicester, UK
Leicester, LE5 4PW, United Kingdom
St. George's Hospital London
London, SW170QT, United Kingdom
Related Publications (17)
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.
PMID: 38710669DERIVEDKleiman 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.
PMID: 38658126DERIVEDO'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: 36515976DERIVEDTuttle 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.
PMID: 35393106DERIVEDLanz 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.
PMID: 34581194DERIVEDMumtaz 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.
PMID: 33217396DERIVEDAttizzani 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.
PMID: 32763073DERIVEDYakubov 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.
PMID: 32723555DERIVEDVan 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.
PMID: 32715995DERIVEDLindman 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.
PMID: 31665959DERIVEDSondergaard 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.
PMID: 31476897DERIVEDReardon 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.
PMID: 31215985DERIVEDHead 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.
PMID: 30929507DERIVEDDurko 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.
PMID: 30360820DERIVEDReardon 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.
PMID: 28304219DERIVEDHaussig 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.
PMID: 26384204DERIVEDPiazza 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.
PMID: 23702009DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peggy Yunker
- Organization
- Medtronic, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Windecker, MD, PhD
Bern University Hospital
- PRINCIPAL INVESTIGATOR
Rüdiger Lange, MD, PhD
Deutsches Herzzentrum München
- PRINCIPAL INVESTIGATOR
Thomas Walther, MD, PhD
Kerckhoff Klinik
- PRINCIPAL INVESTIGATOR
Michael J. Reardon, MD
The Methodist Hospital Research Institute
- PRINCIPAL INVESTIGATOR
David H. Adams, MD
Icahn School of Medicine at Mount Sinai
- STUDY CHAIR
Nicolas M. Van Mieghem, MD
Erasmus Medical Center
- STUDY CHAIR
Patrick W. Serruys, MD, PhD
National Heart & Lung Institute of Imperial College in London
Publication Agreements
- PI is Sponsor Employee
- No
- 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
April 24, 2012
First Posted
April 27, 2012
Study Start
April 1, 2012
Primary Completion
July 1, 2018
Study Completion (Estimated)
November 1, 2026
Last Updated
October 28, 2025
Results First Posted
September 17, 2019
Record last verified: 2025-10