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).

This study is currently recruiting participants.
Verified April 2014 by Medtronic Cardiovascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01586910
First received: April 24, 2012
Last updated: April 16, 2014
Last verified: April 2014
  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.


Condition Intervention
Severe Aortic Stenosis
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Procedure: Surgical Aortic Valve Replacement (SAVR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    All-cause mortality or disabling stroke


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

    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)

  • The occurrence of individual MACCE components [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Major Adverse Events (MAE) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Conduction disturbance requiring permanent pacemaker implantation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Change in NYHA class from baseline [ Time Frame: Baseline through 5 years ] [ Designated as safety issue: No ]
  • Change in distance walked during 6-minute walk test (6MWT) [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
  • Ratio of days alive out of hospital versus total days alive [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of Life (QoL) change from baseline [ Time Frame: Baseline through 5 years ] [ Designated as safety issue: No ]
  • Echocardiographic assessment of prosthetic valve performance [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Cardiovascular deaths and valve-related deaths [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Stroke and TIAs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Peri-procedural neurological injury [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Index procedure related major adverse events (MAEs) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]
  • Length of index procedure hospital stay [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: No ]
  • Presence of atrial fibrillation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Device success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]

    Device success defined as follows:

    • Absence of procedural mortality AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
    • 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

      • Assessed acutely in resting state, either within 24-48 hours after the index procedure or before hospital discharge

  • Procedural success (Medtronic CoreValve® System subjects only) [ Time Frame: Number of days from admission to discharge (expected average of 7 days) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Incidence of Early Safety [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

    Incidence of Early safety at 30 days defined as a composite of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Life-threatening bleeding
    • Acute kidney injury—Stage 2 or 3 (including renal replacement therapy)
    • Coronary artery obstruction requiring intervention
    • Major vascular complication
    • Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
    • All-cause death

  • Incidence of Clinical Efficacy (after 30 days) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    Clinical efficacy defined as a composite of:

    • All-cause mortality
    • All stroke (disabling and non-disabling)
    • Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
    • NYHA class III or IV
    • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA)≤ 0.9-1.1 cm2 and/or doppler velocity index(DVI) < 0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)

  • Incidence of Time-Related Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    Time-Related Safety defined as a composite of:

    • Structural valve deterioration:

      • Valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, EOA ≤ 0.9-1.1 cm2 and/or DVI < 0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
      • Requiring repeat procedure (TAVI or SAVR)
    • Prosthetic valve endocarditis
    • Prosthetic valve thrombosis
    • Thromboembolic events (e.g. stroke)
    • VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)


Estimated Enrollment: 2500
Study Start Date: March 2012
Estimated Primary Completion Date: August 2016 (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)
Active Comparator: SAVR
Surgical Aortic Valve Replacement (SAVR)
Procedure: Surgical Aortic Valve Replacement (SAVR)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have STS mortality risk score ≥4% and ≤10%;
  • Heart Team (consisting of at least one interventional cardiologist and one cardiac surgeon) unanimously agree on indication, treatment proposal, and eligibility for randomization based on their clinical judgment (including anatomy assessment, risk factors, etc.);
  • Subject has severe aortic valve stenosis presenting with

    1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0 cm2 or aortic valve area index < 0.6 cm2/m2 AND
    2. Mean gradient > 40 mmHG or Vmax > 4m/sec by resting echocardiogram [or dobutamine stress echocardiogram if subject has a left ventricular ejection fraction (LEVF) < 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;
  • 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 (including 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;
  • 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;
  • 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-ups 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;

Note: Additional anatomical and vascular exclusion criteria may apply.

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

Contacts
Contact: Todd Fonseca surtavi@medtronic.com
Contact: Francesca Barbieri, MD (EU only) surtavi@medtronic.com

  Show 50 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Study Chair: Patrick W. Serruys, MD, PhD Erasmus Medical Center
Study Chair: Nicolas M Van Mieghem, MD Erasmus Medical Center
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 Bad Nauheim
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 Mount Sinai School of Medicine
Principal Investigator: Jose M Hernandez Servicio de Cardiologia del Hospital Virgen de la Victoria
Principal Investigator: Miguel Such Servicio de Cardiologia del Hospital Virgen de la Victoria
  More Information

No publications provided by Medtronic Cardiovascular

Additional 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 16, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014