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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01586910
First received: April 24, 2012
Last updated: April 18, 2017
Last verified: April 2017
  Purpose

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 sever symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.


Condition Intervention
Severe Aortic Stenosis Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Procedure: Surgical Aortic Valve Replacement (SAVR) (Not applicable for Single Arm) Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • All-cause mortality or disabling stroke [ Time Frame: 24 months ]
    All-cause mortality or disabling stroke


Secondary Outcome Measures:
  • Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [ Time Frame: 5 years ]
    MACCE

  • The occurrence of individual MACCE components [ Time Frame: 5 years ]
  • Major Adverse Events (MAE) [ Time Frame: 5 years ]
  • Conduction disturbance requiring permanent pacemaker implantation [ Time Frame: 5 years ]
  • Change in NYHA class from baseline [ Time Frame: Baseline through 5 years ]
  • Change in distance walked during 6-minute walk test (6MWT) [ Time Frame: Baseline through 24 months ]
  • Ratio of days alive out of hospital versus total days alive [ Time Frame: 12 and 24 months ]
  • Quality of Life (QoL) change from baseline [ Time Frame: Baseline through 5 years ]
  • Echocardiographic assessment of prosthetic valve performance [ Time Frame: 5 years ]
    Measured by transvalvular mean gradient, effective orifice area and degree of prosthetic aortic valve regurgitation (transvalvular and paravalvular)

  • Aortic valve disease related hospitalizations [ Time Frame: 5 years ]
  • Cardiovascular deaths and valve-related deaths [ Time Frame: 5 years ]
  • Stroke and TIAs [ Time Frame: 5 years ]
  • Peri-procedural neurological injury [ Time Frame: 5 years ]
  • Index procedure related major adverse events (MAEs) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ]
  • Length of index procedure hospital stay [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ]
  • Presence of atrial fibrillation [ Time Frame: 5 years ]
  • Device success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ]
    Device success

  • Procedural success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ]
    Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)

  • Evidence of prosthetic valve dysfunction (Medtronic CoreValve® System subjects only) [ Time Frame: 5 years ]
  • Incidence of Early Safety [ Time Frame: 30 Days ]
    Incidence of Early safety at 30 days

  • Incidence of Clinical Efficacy (after 30 days) [ Time Frame: 5 years ]
    Clinical efficacy

  • Incidence of Time-Related Safety [ Time Frame: 5 years ]
    Time-Related Safety

  • Resheath and recapture scuccess (Evolut R only) [ Time Frame: 5 years ]

Estimated Enrollment: 2500
Study Start Date: April 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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) (Not applicable for Single Arm)
Procedure: Surgical Aortic Valve Replacement (SAVR) (Not applicable for Single Arm)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 elgibility 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586910

Contacts
Contact: Mike Boulware surtavi@medtronic.com
Contact: Maarten Hollander (EU) surtavi@medtronic.com

  Show 94 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Stephan Windecker, MD, PhD Bern University Hospital
Principal Investigator: A. Pieter Kappetein, MD, PhD Erasmus Medical Center
Principal Investigator: Rüdiger Lange, MD, PhD Deutsches Herzzentrum München
Principal Investigator: Thomas Walther, MD, PhD Kerckhoff Klinik
Principal Investigator: Jeffrey J. Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael J. Reardon, MD The Methodist Hospital System
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01586910     History of Changes
Other Study ID Numbers: IDE #G120169
Study First Received: April 24, 2012
Last Updated: April 18, 2017

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 18, 2017