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Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients

This study is currently recruiting participants.
Verified October 2017 by Medtronic Cardiovascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02701283
First Posted: March 8, 2016
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiovascular
  Purpose
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.

Condition Intervention
Aortic Valve Stenosis Device: Medtronic Transcatheter Aortic Valve Replacement Systems Device: Surgical Aortic Valve Replacement (SAVR)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • All-cause mortality or disabling stroke [ Time Frame: 2-year ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Health related quality of life assessed by EQ-5D Survey Instrument [ Time Frame: 1year ]

Estimated Enrollment: 1200
Study Start Date: March 2016
Estimated Study Completion Date: March 2026
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Active Comparator: Surgical Aortic Valve Replacement (SAVR)
Treatment of Aortic Stenosis with commercial Surgical Aortic Valve Replacement (SAVR)
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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

    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, 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, 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, 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 TAV, or <6.0 mm for patent LIMA, or access vessel mean diameter <5.5 mm for Evolut 34R and TAVR 2.0 TAV or <6.0 mm for patent LIMA, or access vessel mean diameter <6 mm for CoreValve 31 mm TAV.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701283


Contacts
Contact: Joleen Perkins 1-763-514-9731 joleen.perkins@medtronic.com
Contact: Jennifer Maloney +17635058644 jennifer.s.maloney@medtronic.com

  Show 74 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Principal Investigator: Jeffrey Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Michael Reardon, MD The Methodist Hospital System
  More Information

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02701283     History of Changes
Other Study ID Numbers: 10234430Doc
First Submitted: February 26, 2016
First Posted: March 8, 2016
Last Update Posted: November 16, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction