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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635424
Recruitment Status : Active, not recruiting
First Posted : August 17, 2018
Results First Posted : December 21, 2020
Last Update Posted : May 3, 2021
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)
Actual Enrollment : 150 participants
Allocation: N/A
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 : October 30, 2018
Actual Primary Completion Date : November 13, 2019
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine


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. Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of of all-cause mortality or disabling stroke rate at 30 days

  2. Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure. [ 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. Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)

  4. Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure. [ Time Frame: 30 days ]
    The rate of myocardial infarction at 30 days

  5. Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of life-threatening (or disabling) bleeding at 30 days

  6. Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of prosthetic valve endocarditis at 30 days

  7. Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of prosthetic valve thrombosis at 30 days

  8. Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of valve-related dysfunction requiring repeat procedure at 30 days

  9. Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of repeat hospitalization for aortic valve disease at 30 days

  10. Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure. [ Time Frame: 30 days ]
    Rate of repeat hospitalization for ascending aorta disease at 30 days

  11. Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  12. Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days. [ Time Frame: 30 days ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  13. Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure

  14. Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure

  15. Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure

  16. New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days [ Time Frame: 30 days ]

    Reporting of NYHA classification change from baseline to 30 days

    NYHA Classification criteria:

    Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

    Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

    Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

    Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.


  17. Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days [ Time Frame: 30 days ]

    QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures:

    • KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.


  18. Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days. [ Time Frame: 30 days ]

    QoL summary scores and change from baseline using the following measures:

    • EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state




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


Locations
Show Show 25 study locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Study Chair: Michael Reardon, MD The Methodist Hospital Research Institute
Principal Investigator: John Forrest, MD Yale University
Principal Investigator: Basel Ramlawi, MD Winchester Medical Center
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiovascular:
Study Protocol  [PDF] January 31, 2019
Statistical Analysis Plan  [PDF] January 16, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT03635424    
Other Study ID Numbers: 10790330DOC
First Posted: August 17, 2018    Key Record Dates
Results First Posted: December 21, 2020
Last Update Posted: May 3, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases