SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)
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| ClinicalTrials.gov Identifier: NCT04722250 |
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Recruitment Status :
Active, not recruiting
First Posted : January 25, 2021
Last Update Posted : April 8, 2024
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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, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems | Not Applicable |
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+/FX 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, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.)
- 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 716 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 |
| Actual Primary Completion Date : | November 10, 2023 |
| Estimated Study Completion Date : | December 2027 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available) |
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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.
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Device: Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System |
- Mortality, disabling stroke or heart failure rehospitalization [ Time Frame: 12 months ]Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
- 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.
- Percentage of participants with BVD in female subjects [ Time Frame: 12 months ]
- Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD) [ Time Frame: 12 months ]
- Aortic valve mean gradient as a continuous variable [ Time Frame: 12 months ]
- Effective Orifice Area (EOA) as a continuous variable [ Time Frame: 12 months ]
- Rate of moderate or severe prothesis-patient mismatch (PPM) [ Time Frame: 30 days ]
- Device success [ Time Frame: 30 days ]
- 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)
- Hospital readmission rate for any cause [ Time Frame: 30 days ]
- 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)
- 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 ]
- New pacemaker implantation rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
- Aortic valve re-intervention rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
- 6-minute walk test (6MWT) change from baseline [ Time Frame: 30 days, 12 months and annually to 5 years ]
- 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
- 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
- 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
- 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)).
- Mean gradient ≥ 20 mmHg based on stress echocardiogram [ Time Frame: 12 months ]Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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+/FX 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+/FX 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
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
Show 92 study locations
| 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 |
| Responsible Party: | Medtronic Cardiovascular |
| ClinicalTrials.gov Identifier: | NCT04722250 |
| Other Study ID Numbers: |
MDT20023EVR012 |
| First Posted: | January 25, 2021 Key Record Dates |
| Last Update Posted: | April 8, 2024 |
| Last Verified: | April 2024 |
| 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 |
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Aortic Valve Stenosis Constriction, Pathologic Pathological Conditions, Anatomical Aortic Valve Disease |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction |