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

Primary Purpose

Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems

Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

About this trial

This is an interventional treatment trial for Symptomatic Aortic Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Scripps Memorial Hospital
Cedars Sinai Medical Center
Sutter Health
Los Robles Hospital and Medical Center
University of Colorado
Yale New Haven Hospital
WHC Washington MedStar
Morton Plant Hospital
HealthPark Medical Center
University of Florida
Mount Sinai Medical Center
Emory Structural Heart Clinic and Emory University Midtown
Piedmont Atlanta Hospital
Wellstar Kennestone Hospital
NorthShore Health Systems
Advocate Christ Medical Center
Saint Vincent Heart Center of Indiana
University of Iowa Hospitals and Clinics
University of Kansas Medical Center
AscensionVia Christi St. Francis Hospital
Tufts Medical Center
University of Michigan
Ascension St. John Hospital
Spectrum Health
Mayo Clinic
St. Cloud Hospital
Missouri Baptist Medical Center
Morristown Medical Center
Buffalo General Medical Center
NYU Langone Medical Center
The Icahn School of Medicine at Mount Sinai
Weill Cornell Medical Center
Mission Hospital
UNC Memorial Hospital
TriHealth / Bethesda North Hospital
University Hospitals Cleveland Medical Center
Cleveland Clinic Foundation
Hillcrest Medical Center
UPMC Pinnacle Harrisburg
Hospital of the University of Pennsylvania
Penn Presbyterian Medical Center
Allegheny General Hospital
UPMC Presbyterian
Lankenau Medical Center
York Hospital
TriStar Centennial Medical Center
St. Thomas West Hospital
Seton Heart Institute
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Texas Health Presbyterian Hospital/Dallas
Baylor Saint Luke's Hospital
Houston Methodist Hospital
The University of Texas Health Science Center at Houston
University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure
The Heart Hospital Baylor Plano
Intermountain Medical Center
Saint George Regional Hospital
University of Virginia
Inova Fairfax Hospital
Sentara Norfolk General Hospital
J.W. Ruby Memorial Hospital/West Virginia University
Providence Health-St. Paul's Hospital
Victoria Heart Institute Foundation/Royal Jubilee Hospital
Toronto General Hospital
St. Michaels Hospital/Unity Health Toronto
Montreal Heart Institute
Rigshospitalet
Helsinki University Hospital
Centre Hospitalier Universitaire de Clermont-Ferrand
CHU Bordeaux
Clinique Pasteur
Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum
Deutsches Herzzentrum Berlin
Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund
Universitätsklinikum Düsseldorf
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Helios Health Institute GmbH
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Deutsches Herzzentrum Munchen
Sheba Medical Center
Tel Aviv Sourasky Medical Center
Policlinico Sant' Orsala - Malpighi
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
AOU Integrata Verona
HagaZiekenhuis - Locatie Leyweg
Catharina Ziekenhuis
Maastricht Universitair Medisch Centrum (MUMC)
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Hospital Vall d'Hebron
Inselspital - Universitätsspital Bern
Royal Infirmary of Edinburgh
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Medtronic Self-Expanding TAV

Edwards Balloon-Expandable THV

Arm Description

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Outcomes

Primary Outcome Measures

Mortality, disabling stroke or heart failure rehospitalization

Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.

Bioprosthetic Valve Dysfunction (BVD)

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

Percentage of participants with BVD in female subjects

Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD)

Aortic valve mean gradient as a continuous variable

Effective Orifice Area (EOA) as a continuous variable

Rate of moderate or severe prothesis-patient mismatch (PPM)

Full Information

NCT ID

NCT04722250

First Posted

January 20, 2021

Last Updated

October 17, 2023

Sponsor

Medtronic Cardiovascular

1. Study Identification

Unique Protocol Identification Number

NCT04722250

Brief Title

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Acronym

SMART

Official Title

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 2, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiovascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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+/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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

716 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Medtronic Self-Expanding TAV

Arm Type

Experimental

Arm Description

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Arm Title

Edwards Balloon-Expandable THV

Arm Type

Experimental

Arm Description

Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.

Intervention Type

Device

Intervention Name(s)

Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems

Intervention Description

TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)

Intervention Type

Device

Intervention Name(s)

Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

Intervention Description

TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Primary Outcome Measure Information:

Title

Mortality, disabling stroke or heart failure rehospitalization

Description

Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.

Time Frame

12 months

Title

Bioprosthetic Valve Dysfunction (BVD)

Description

Percentage of participants with BVD (hemodynamic structural valve dysfunction, non-structural valve dysfunction, thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Percentage of participants with BVD in female subjects

Time Frame

12 months

Title

Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD)

Time Frame

12 months

Title

Aortic valve mean gradient as a continuous variable

Time Frame

12 months

Title

Effective Orifice Area (EOA) as a continuous variable

Time Frame

12 months

Title

Rate of moderate or severe prothesis-patient mismatch (PPM)

Time Frame

30 days

Other Pre-specified Outcome Measures:

Title

Device success

Time Frame

30 days

Title

Incidence of an early safety composite

Description

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)

Time Frame

30 days

Title

Hospital readmission rate for any cause

Time Frame

30 days

Title

Incidence of clinical efficacy

Description

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)

Time Frame

12 months and annually through 5 years

Title

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

Title

New pacemaker implantation rate

Time Frame