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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI); Procedure: Surgical Aortic Valve Replacement (SAVR)

• Study Type: Interventional
• Enrollment (Actual): 1746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Montreal, Canada
    • Montreal Heart Institute
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre, University Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital (University Health Network)
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Health Center - Royal Victoria Hospital
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
• Germany
  • Bad Krozingen, Germany, 79106
    • Universitäts-Herzzentrum Freiburg • Bad Krozingen
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Munich, Germany
    • Deutsches Herzzentrum Muenchen
• Netherlands
  • Breda, Netherlands
    • Amphia hospital Breda
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Nieuwegein, Netherlands
    • St. Antonius Hospital, R & D Cardiology
  • Rotterdam, Netherlands
    • Erasmus Medical Center - Rotterdam
• Spain
  • Malaga, Spain
    • Servicio de Cardiologia del Hospital Virgen de la Victoria
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Stockholm
• Switzerland
  • Bern, Switzerland
    • Bern University Hospital
  • Zurich, Switzerland
    • Universitatsspital Zurich
• United Kingdom
  • Leeds, United Kingdom
    • Leeds General Infirmary
  • Leicester, United Kingdom, LE5 4PW
    • Glenfield Hospital, Leicester, UK
  • London, United Kingdom, SW170QT
    • St. George's Hospital London
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
  • California
    • Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Pasadena, California, United States, 91101
      • Southern California Permenente Medical Group
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06520-8047
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare, Inc.
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center / Mercy Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5864
      • University of Michigan Health Systems
    • Detroit, Michigan, United States, 48202
      • Henry Ford
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Center
    • Detroit, Michigan, United States, 48201-2018
      • Detroit Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott NW - MN Heart Institute Foundation
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - St. Mary's Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital/MAHI
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Alegent Creighton Health Research Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Healthcare System
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • The OhioHealth Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Institute
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Stern Cardiovascular
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • The Methodist DeBakey Heart & Vascular Center
    • Plano, Texas, United States, 75093
      • The Heart Hospital - Baylor Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular
    • Richmond, Virginia, United States, 23226
      • Bon Secours St. Mary's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

  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:

• 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;
• 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: Additional anatomical and vascular exclusion criteria may apply.

Note: * For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic CoreValve® System TAVI; Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: SAVR; Surgical Aortic Valve Replacement (SAVR)	Procedure: Surgical Aortic Valve Replacement (SAVR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	MACCE is defined as a composite of: All-cause death; Myocardial infarction (MI); All stroke, and; Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)	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	MACCE is defined as a composite of: All-cause death; Myocardial infarction (MI); All stroke, and; Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)	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)	Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.	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	Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.	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.
Change in Distance Walked During 6-minute Walk Test (6MWT)	Change in distance walked during 6MWT from baseline	From baseline to 30 days, baseline to 12 months, and baseline to 24 months
Ratio of Days Alive Out of Hospital Versus Total Days Alive		12 and 24 months
Quality of Life (QoL) Change From Baseline	QoL summary score change from baseline using the following measures: Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.; 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.; European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.	Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance	Using the following measure: -Transvalvular mean gradient	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Effective Orifice Area as an Assessment of Prosthetic Valve Performance	Using the following measure: -Effective Orifice Area (cm^2)	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance	Using the following measure: - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Percentage of Participants With Aortic Valve Disease Related Hospitalizations		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 Cardiovascular Deaths and Valve-Related Deaths		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 Stroke and TIAs	Strokes (of any severity) and Transient Ischemic Attacks (TIAs)	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Peri-procedural Neurological Injury	Neurological injury (stroke, TIA, or encephalopathy)	discharge or 7 days post index procedure (whichever occurred first)
Index Procedure Related Major Adverse Events (MAEs)	Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.	Procedure through 30 day visit
Length of Index Procedure Hospital Stay		Number of days from admission to discharge (expected average of 7 days)
Presence of Atrial Fibrillation		post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Device Success (Medtronic CoreValve® System Subjects Only)	Absence of procedural mortality; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)	Number of days from admission to discharge (expected average of 7 days)
Procedural Success (Medtronic CoreValve® System Subjects Only)	Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)	Number of days from admission to discharge (expected average of 7 days)
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)	Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR; moderate or severe total AR	6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Percentage of Participants With Early Safety Endpoint	Percentage of participants with VARC II early safety composite at 30 days	30 Days
Percentage of Participants With Clinical Efficacy (After 30 Days)	Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.	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 Time-Related Safety	The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
Resheath and Recapture Success (Evolut R Only)	The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.	Procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): July 1, 2018
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 24, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimated): April 27, 2012

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: IDE #G120169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes