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Medtronic CoreValve SURTAVI Trial -Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Description

SURTAVI Clinical Investigation Protocol: Background:Purpose:The purpose of this 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 or Medtronic EVOLUT-R system.Objectives:The primary objective of this trial is to evaluate in a prospective randomized fashion whether TAVI is non-inferior to SAVR with respect to composite endpoint of all-cause mortality and disabling stroke at 24 months in patients with symptomatic severe aortic stenosis and at intermediate surgical risk.The secondary objective of this trial is to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with symptomatic severe aortic stenosis and at intermediate risk treated with either Transcatheter Aortic Valve Implantation (TAVI) or Surgical Aortic Valve Replacement (SAVR).Study population:Patients who have symptomatic severe Aortic Stenosis at intermediate surgical risk defined by a Society of Thoracic Surgeons (STS) mortality risk of 4% and 10% will be presented to the Heart Team for inclusion in the trial.Methodology/study arms:This study is designed as a prospective, multi-center, multi-national, randomized, interventional trial to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk. Approximately 1600 subjects will be recruited in up to 115 investigational centers located in the United States, Canada and Europe. The study may be expanded to include additional geographies based on enrollment rates and identification of qualified centers. Subjects will be randomized on a 1:1 basis to either transcatheter aortic valve implant (TAVI) with one of two approved valves, Medtronic CoreValve System (MCS)/EVOLUT R System or to surgical aortic valve replacement (SAVR).Primary Endpoint:All-cause mortality or disabling stroke at 24 months Follow-up: Subjects will be followed through 5 years with assessments at 30 days, 3 months, 6 months, 12 months, 18 months, 24 months, and 3, 4, and 5 years post MCS TAVI or post SAVR.Statistics/Analysis:The statistical analysis will be performed by the statistics department of Medtronic. As primary analysis all randomized subjects will be analyzed following the modified intention to treat (mITT) approach; i.e. analyses will be conducted on the cohort of subjects who undergo an attempted study treatment, analyzed according to the randomized assignment. A secondary analysis of key objectives will be performed according to the therapy actually received. SURTAVI Single-Arm, Non-Randomized Phase (Addendum Version 1.0): Background: The Medtronic CoreValve SURTAVI Trial is a prospective, randomized, multicenter investigational trial. The purpose of this trial is to investigate the safety and effectiveness 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. The purpose of this addendum to the Medtronic CoreValve SURTAVI Trial protocol is to conclude the randomized phase and initiate the single-arm, non-randomized, TAVI only phase of the trial. Objectives: The primary objective of this trial is to evaluate the safety and effectiveness of the Medtronic CoreValve System and CoreValve Evolut R System, as measured by a composite endpoint of all-cause mortality or disabling stroke at 24 months in patients with symptomatic severe aortic stenosis and at intermediate surgical risk. Patient Population: Patients who have symptomatic severe Aortic Stenosis who are determined by the Heart Team to be at intermediate surgical risk. Design: The single-arm phase is designed as a prospective, multi-center in the United States, non-randomized, interventional trial to evaluate the safety and effectiveness of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk. All enrolled subjects will be assigned to transcatheter aortic valve implant (TAVI). Follow-Up: All enrolled subjects will undergo in-clinic follow-up evaluations at the following time points post implant, 30 days, 6 months, 12 months, 24 months and annually thereafter through 5 years. In the single-arm phase of this trial, the 3 months and 18 months follow-up visits are no longer required like in the primary SURTAVI Trial Clinical Investigation Protocol (CIP). Statistical Analysis: There are three analysis populations defined for this study. The primary analysis for the primary objective and most secondary objectives will use the attempted implant population. The echocardiographic assessment of valve performance data will be analyzed based on the implanted population. (1)All enrolled population all subjects who are enrolled in the trial (2) Attempted implant population - all subjects in whom a procedure is attempted. A procedure attempt is defined as when the subject is brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed or any monitoring line placed. (3) Implanted population All attempted implant subjects who are actually implanted with the investigational TAVI device.

Phase

N/A

Inclusion and Exclusion 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 elgibility 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;

  • - 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:
  • Subject is < 80 years of age and three or more of the following apply
  • 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.

Sites

  • California

    • Keck Medical Center of USC, Los Angeles, California, 90033
    • Southern California Permenente Medical Group, Pasadena, California, 91101
    • Cedars-Sinai Medical Center, Hollywood, California, 90048
    • Scripps Green Hospital, La Jolla, California, 92037
    • El Camino Hospital, Mountain View, California, 94040
    • VA Palo Alto Health Care System, Palo Alto, California, 94304
  • Arizona

    • Banner Good Samaritan Medical Center, Phoenix, Arizona, 85006
  • Utah

    • Intermountain Medical Center, Murray, Utah, 84107
  • Oklahoma

    • Oklahoma Heart Institute, Oklahoma, Oklahoma, 73120
  • Texas

    • CRSTI/The Heart Hospital - Baylor Plano, Plano, Texas, 75093
    • Baylor Research Institute, Dallas, Texas, 75204
    • Baylor Heart and Vascular Hospital, Dallas, Texas, 75226
    • Methodist DeBakey Heart & Vascular Center, Houston, Texas, 77030
  • Nebraska

    • Alegent Creighton Health Research Center, Omaha, Nebraska, 68124
  • Kansas

    • University of Kansas Hospital, Kansas City, Kansas, 66160
  • Iowa

    • Iowa Heart Center / Mercy Medical Center, West Des Moines, Iowa, 50266
  • Minnesota

    • Abbott NW - MN Heart Institute Foundation, Minneapolis, Minnesota, 55407
    • Mayo Clinic - St. Mary's Hospital, Rochester, Minnesota, 55905
  • Tennessee

    • Baptist Memorial Hospital Memphis, Memphis, Tennessee, 38120
    • Vanderbilt University Medical Center, Nashville, Tennessee, 37232
  • Louisiana

    • Cardiovascular Institute of the South, Houma, Louisiana, 70360
  • Illinois

    • Loyola University of Chicago, Mayowood, Illinois, 60153
  • Wisconsin

    • Aurora St. Luke's Medical Center, Milwaukee, Wisconsin, 53215
  • Indiana

    • St. Vincent Heart Center of Indiana, Indianapolis, Indiana, 46290
  • Michigan

    • Spectrum Health Hospitals, Grand Rapids, Michigan, 49503
  • Ohio

    • Good Samaritan Hospital, Cincinnati, Ohio, 45220
  • Georgia

    • Piedmont Healthcare, Inc., Atlanta, Georgia, 30309
    • Emory University, Atlanta, Georgia, 30308
  • Germany

    • Universitäts-Herzzentrum Freiburg • Bad Krozingen, Bad Krozingen, 79106
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