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Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

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ClinicalTrials.gov Identifier: NCT03635424
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Condition or disease Intervention/treatment Phase
Bicuspid Aortic Valve Device: Medtronic TAVR Systems Not Applicable

Detailed Description:

Multi‐center, prospective, single arm

All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
Experimental: Medtronic TAVR Systems
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems
Device: Medtronic TAVR Systems
Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems




Primary Outcome Measures :
  1. Device and procedure safety: All‐cause mortality or disabling stroke rate [ Time Frame: 30 days ]
    All‐cause mortality or disabling stroke rate

  2. Device and Procedure Efficacy: Device success rate [ Time Frame: 7 days ]

    Device success rate, defined as:

    • Absence of procedural mortality, AND
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
    • Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)


Secondary Outcome Measures :
  1. All‐cause mortality rate [ Time Frame: 1 year and annually through 10 years ]
    Rate of all cause mortality

  2. All stroke (disabling and non‐disabling) rate [ Time Frame: 1 year and annually through 10 years ]
    Rate of disabling and non-disabling strokes

  3. New permanent pacemaker implantation rate [ Time Frame: 30 days ]
    Rate of new permanent pacemaker implantation

  4. Myocardial infarction at 30 days [ Time Frame: 30 days ]
    Myocardial infarction at 30 days

  5. Life‐threatening bleeding rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of life-threatening bleeding

  6. Prosthetic valve endocarditis rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of prosthetic valve endocarditis

  7. Prosthetic valve thrombosis rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of prosthetic valve thrombosis

  8. Valve‐related dysfunction requiring repeat procedure rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of valve-related dysfunction requiring repeat procedure

  9. Repeat hospitalization for aortic valve disease rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of repeat hospitalization for aortic valve disease

  10. Repeat hospitalization for ascending aorta disease rate [ Time Frame: 30 days, one year, and annually though 10 years ]
    Rate of repeat hospitalization for ascending aorta disease

  11. Change in hemodynamic performance (mean aortic valve gradient) by Doppler echocardiography [ Time Frame: Baseline, 30 days, one year, and annually though 5 years, and at years 7 and 10 ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by mean aortic valve gradient

  12. Change in Hemodynamic performance (effective orifice area) by Doppler echocardiography [ Time Frame: Baseline, 30 days, one year, and annually though 5 years, and at years 7 and 10 ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  13. Change in Hemodynamic performance (degree of total, peri, and transvalvular prosthetic regurgitation) by Doppler echocardiography [ Time Frame: Baseline, 30 days, one year, and annually though 5 years, and at years 7 and 10 ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by degree of total, peri, and transvalvular prosthetic regurgitation.

  14. Change in New York Heart Association (NYHA) functional classification [ Time Frame: Baseline, 30 days, one year, and annually though 5 years, and at years 7 and 10 ]
    Change in NYHA functional classification

  15. Change in Health-related quality of life as assessed by Kansas City Cardiomyopathy (KCCQ) instrument [ Time Frame: Baseline, 30 days, one year, annually through 5 years ]
    Change in health-related quality of life assessed by Kansas City Cardiomyopathy

  16. Change in Health-related quality of life as assessed by EQ-5D survey [ Time Frame: Baseline, 30 days, and one year ]
    Change in health-related quality of life as assessed by EQ-5D survey



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.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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 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. Patient is considered 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. Bicuspid aortic valve anatomy (all sub‐types) confirmed by MDCT.
  4. 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. Age less than 60 years
  3. 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
  4. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  5. Ongoing sepsis, including active endocarditis.
  6. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval.
  7. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
  8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
  9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  10. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  11. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  12. Subject refuses a blood transfusion.
  13. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
  14. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
  15. 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.
  16. Currently participating in an investigational drug or another device study (excluding registries).
  17. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria).
  18. Need for emergency surgery for any reason.
  19. Subject is pregnant or breast feeding.
  20. Subject is legally incompetent, or otherwise vulnerable

    Anatomical exclusion criteria:

  21. Pre-existing prosthetic heart valve in any position.
  22. Severe mitral regurgitation amenable to surgical replacement or repair.
  23. Severe tricuspid regurgitation amenable to surgical replacement or repair.
  24. Moderate or severe mitral stenosis amenable to surgical replacement or repair.
  25. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
  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 ascending aortopathy requiring surgical repair
  30. Ascending aorta diameter > 4.5 cm

    For transfemoral or transaxillary (subclavian) access:

  31. 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 23R, 26R, 29 R mm 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.

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): NCT03635424


Contacts
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Contact: Hatice Bilgic Lim, PhD 763-526-1018 hatice.bilgic.lim@medtronic.com
Contact: TAVR Low Risk Team rs.lowriskbicuspid@medtronic.com

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Study Chair: Jeffrey Popma, MD Beth Israel Deaconess Medical Center
Study Chair: Michael Reardon, MD The Methodist Hospital System
Principal Investigator: John Forrest, MD Yale University
Principal Investigator: Basel Ramlawi, MD Winchester Medical Center

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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT03635424     History of Changes
Other Study ID Numbers: 10790330DOC
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases