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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

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ClinicalTrials.gov Identifier: NCT02701283
Recruitment Status : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date October 30, 2019
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
All-cause mortality or disabling stroke [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02701283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
  • Composite of death, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) [ Time Frame: 30 days ]
  • Number of patients with new permanent pacemaker implantation [ Time Frame: 30 days ]
  • Number of patients with prosthetic valve endocarditis per the Duke criteria [ Time Frame: 1 year ]
  • Prosthetic valve thrombosis [ Time Frame: 1 year ]
  • All stroke (disabling and non-disabling) [ Time Frame: 1 year ]
  • Number of patients with life-threatening bleed [ Time Frame: 1 year ]
  • Number of patients with valve-related dysfunction requiring repeat procedure [ Time Frame: 1 year ]
  • Number of patients with valve-related dysfunction (moderate or severe stenosis or regurgitation) [ Time Frame: 1 year ]
  • Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) [ Time Frame: 30 days and 1 year ]
  • Number of patients with repeat hospitalization for signs and symptoms of aortic valve disease [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Composite of death, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) [ Time Frame: 30 days ]
  • Number of patients with new permanent pacemaker implantation [ Time Frame: 30 days ]
  • Number of patients with prosthetic valve endocarditis per the Duke criteria [ Time Frame: 1 year ]
  • Prosthetic valve thrombosis [ Time Frame: 1 year ]
  • All stroke (disabling and non-disabling) [ Time Frame: 1 year ]
  • Number of patients with life-threatening bleed [ Time Frame: 1 year ]
  • Number of patients with valve-related dysfunction requiring repeat procedure [ Time Frame: 1 year ]
  • Number of patients with valve-related dysfunction (moderate or severe stenosis or regurgitation) [ Time Frame: 1 year ]
  • Quality of Life as assessed by Kansas City Cardiomyopathy (KCCQ) [ Time Frame: 1 year ]
  • Number of patients with repeat hospitalization for signs and symptoms of aortic valve disease [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures
 (submitted: October 30, 2018)
  • Health related quality of life assessed by EQ-5D Survey Instrument [ Time Frame: 1 year ]
    The EQ-5D was developed by the Euro-Qol Group and is a survey instrument designed to measure quality of life across 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). The survey is comprised of a descriptive system and a visual analogue scale where subjects rate their current state of health.
  • New York Heart Association (NYHA) functional classification [ Time Frame: 1 year ]
  • Hemodynamic performance as measured by mean aortic gradient at one year by Doppler echocardiography [ Time Frame: 1 year ]
  • Device success (VARC II) [ Time Frame: 30 days and through annual visits to 10 years ]
    The VARC II definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mm Hg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation
  • Hemodynamic performance as measured by effective orifice area at one year by Doppler echocardiography [ Time Frame: 1 year ]
  • Hemodynamic performance as measured by degree of total, peri, and transvalvular prosthetic regurgitation at one year by Doppler echocardiography [ Time Frame: 1 year ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Official Title  ICMJE Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement
Brief Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Detailed Description

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Valve Stenosis
Intervention  ICMJE
  • Device: Medtronic Transcatheter Aortic Valve Replacement Systems
    Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems
  • Device: Surgical Aortic Valve Replacement (SAVR)
    Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis
Study Arms  ICMJE
  • Experimental: Medtronic Transcatheter Aortic Valve Replacement Systems
    Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
    Intervention: Device: Medtronic Transcatheter Aortic Valve Replacement Systems
  • Active Comparator: Surgical Aortic Valve Replacement (SAVR)
    Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
    Intervention: Device: Surgical Aortic Valve Replacement (SAVR)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
1411
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)
1250
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Severe aortic stenosis, defined as follows:

    1. For symptomatic patients:

      Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

    2. For asymptomatic patients:

      • Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
      • Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
  2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
  3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

  1. Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
  2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

    1. aspirin or heparin (HIT/HITTS) and bivalirudin
    2. ticlopidine and clopidogrel
    3. Nitinol (titanium or nickel)
    4. contrast media
  3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  4. Ongoing sepsis, including active endocarditis.
  5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
  6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  10. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  11. Subject refuses a blood transfusion.
  12. 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).
  13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  14. 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.
  15. Currently participating in an investigational drug or another device trial (excluding registries).
  16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
  17. Need for emergency surgery for any reason.
  18. Subject is pregnant or breast feeding.
  19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
  20. Pre-existing prosthetic heart valve in any position.
  21. Severe mitral regurgitation amenable to surgical replacement or repair.
  22. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  23. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
  26. Prohibitive left ventricular outflow tract calcification.
  27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
  28. Aortic annulus diameter of <18 or >30 mm.
  29. Significant aortopathy requiring ascending aortic replacement.

    For transfemoral or transaxillary (subclavian) access:

  30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Japan,   Netherlands,   New Zealand,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701283
Other Study ID Numbers  ICMJE 10234430Doc
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiovascular
Study Sponsor  ICMJE Medtronic Cardiovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael Reardon, MD The Methodist Hospital System
PRS Account Medtronic Cardiovascular
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP