Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)

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.
 
ClinicalTrials.gov Identifier: NCT04722250
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.


Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Aortic Valve Stenosis Aortic Valve Replacement Device: Medtronic Evolut PRO or Evolut PRO+ TAV Systems Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems Not Applicable

Detailed Description:

This is a prospective, multi-center, international, randomized controlled, post-market trial.

The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure.

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.

Product Names:

  • Medtronic Evolut PRO and Evolut PRO+ TAV Systems
  • Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems

The exercise stress echocardiographic testing at select SMART Trial sites seeks to evaluate the performance of the prosthetic aortic valve during exercise. The stress echocardiogram assessment will be conducted as part of the 12-month visit for participating subjects.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Medtronic Self-Expanding TAV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Device: Medtronic Evolut PRO or Evolut PRO+ TAV Systems
TAVR treatment with Medtronic Evolut PRO or PRO+ System

Experimental: Edwards Balloon-Expandable THV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System




Primary Outcome Measures :
  1. Mortality, disabling stroke or heart failure rehospitalization [ Time Frame: 12 months ]
    Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.

  2. Bioprosthetic Valve Dysfunction (BVD) [ Time Frame: 12 months ]
    Percentage of participants with BVD (hemodynamic structural valve dysfunction, non-structural valve dysfunction, thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.


Secondary Outcome Measures :
  1. Percentage of participants with BVD in female subjects [ Time Frame: 12 months ]
  2. Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD) [ Time Frame: 12 months ]
  3. Aortic valve mean gradient as a continuous variable [ Time Frame: 12 months ]
  4. Effective Orifice Area (EOA) as a continuous variable [ Time Frame: 12 months ]
  5. Rate of moderate or severe prothesis-patient mismatch (PPM) [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Device success [ Time Frame: 30 days ]
  2. Incidence of an early safety composite [ Time Frame: 30 days ]

    Incidence of an early safety composite at 30 days defined as:

    • 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, TAVR, or SAVR)

  3. Hospital readmission rate for any cause [ Time Frame: 30 days ]
  4. Incidence of clinical efficacy [ Time Frame: 12 months and annually through 5 years ]

    Incidence of clinical efficacy (after 30 days) at 12 months and annually to 5 years 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, EOA ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0. 35m/s, AND/OR moderate or severe prosthetic valve regurgitation)

  5. Percentage of participants with individual clinical endpoint components including mortality, disabling stroke and heart failure rehospitalization [ Time Frame: 12 months and annually to 5 years ]
  6. New pacemaker implantation rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
  7. Aortic valve re-intervention rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
  8. 6-minute walk test (6MWT) change from baseline [ Time Frame: 30 days, 12 months and annually to 5 years ]
  9. Quality of Life (QoL) change from baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ] [ Time Frame: 30 days, 12 months and annually to 5 years ]
    QoL: KCCQ

  10. Quality of Life (QoL) change from baseline EuroQol- 5 Dimension [EQ-5D]) [ Time Frame: 30 days, 12 months and annually to 5 years ]
    QoL: EQ-5D

  11. BVD [ Time Frame: 2 to 5 years annually ]

    BVD at 2 to 5 years annually post-procedure including any of the following:

    • Hemodynamic structural valve dysfunction (HSVD)
    • Non-structural valve dysfunction (NSVD)
    • Thrombosis
    • Endocarditis
    • Aortic valve re-intervention

  12. Echocardiographic measurements [ Time Frame: Discharge, 30 days, 12 months and annually to 5 years ]
    Echocardiographic measurements (i.e. EOA, mean gradient, peri-valvular leak (PVL), left ventricular mass regression, and DVI (severe <0.25, moderate 0.25-0.5, mild >0.5)).

  13. Mean gradient ≥ 20 mmHg based on stress echocardiogram [ Time Frame: 12 months ]
    Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)
  • Subject has a predicted risk of operative mortality < 15% as determined by the local Heart Team
  • Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
  • Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)
  • Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+ TAV and Edwards SAPIEN 3/3 Ultra TAV
  • Subject's anatomy is suitable for TAVR via transfemoral vessel access
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

  • Estimated life expectancy of fewer than 2 years
  • Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).
  • Participating in another trial that may influence the outcome of this trial
  • Need for an emergent procedure for any reason
  • Contraindicated for treatment with the Evolut PRO/PRO+ and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
  • 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
  • Pregnant, nursing, or planning to be pregnant
  • Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
  • Subject has an active COVID-19 infection or relevant history of COVID-19
  • Previous aortic valve replacement

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): NCT04722250


Contacts
Layout table for location contacts
Contact: SMART Trial Clinical Study Team 763-514-4000 rs.smarttrial@medtronic.com

Locations
Show Show 76 study locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
Layout table for investigator information
Principal Investigator: Howard Herrmann, MD University of Pennsylvania, United States
Principal Investigator: Roxana Mehran, MD Mount Sinai School of Medicine, United States
Principal Investigator: Didier Tchétché, MD Clinique Pasteur Toulouse, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT04722250    
Other Study ID Numbers: MDT20023EVR012
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction