Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1127 participants
OBSERVATIONAL
2019-09-16
2024-11-13
Brief Summary
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The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Detailed Description
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The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Cohort
Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Aortic valve replacement
Interventions
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Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Aortic valve replacement
Eligibility Criteria
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Inclusion Criteria
* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
* Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits;
* Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system;
* Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria
* Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable);
* Previous aortic valve replacement
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<35% as measured by resting echocardiogram;
* Frailty assessments identify:
* Subject is \<80 years of age and three or more of the following apply; OR subject is \> 80 years of age and two or more of the following apply
* Wheelchair bound
* Resides in an institutional care facility (e.g. nursing home, skilled care center)
* Body Mass Index \<20kg/m2
* Grip strength \<16kg
* Katz Index score ≤4
* Albumin \<3.5 g/dL
* Bicuspid valve verified;
* Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \> 70°.
* Implanted with pacemaker or ICD;
* Prohibitive left ventricular outflow tract calcification;
* Estimated life expectancy of less than 12 months due to associated non- cardiac co-morbid conditions;
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent, adherence to the protocol required follow-up exams;
* Currently participating in an investigational drug or another device trial (excluding registries);
* Need for emergency surgery for any reason.
* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\*.
* Notes: Vulnerable subjects include individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. EXAMPLE Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Yakubov, MD
Role: PRINCIPAL_INVESTIGATOR
OhioHealth
Kendra Grubb, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Josep Rodés-Cabau, MD
Role: STUDY_CHAIR
Laval University
Suneet Mittal, MD
Role: STUDY_CHAIR
Valley Health System
Tamim Nazif, MD
Role: STUDY_CHAIR
Columbia - New York Presbyterian
Hemal Gada, MD
Role: STUDY_CHAIR
UPMC Pinnacle
Douglas Fraser, MD
Role: STUDY_CHAIR
Manchester Royal Infirmary
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
California Pacific Medical Center - Sutter Health
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
St. John's Hospital/Prarie Education and Research Cooperative
Springfield, Illinois, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital (Minneapolis Heart)
Minneapolis, Minnesota, United States
Providence St. Patrick Hospital
Missoula, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
The Mount Sinai Hospital
New York, New York, United States
New York Presbyterian - Columbia University Medical Center
New York, New York, United States
Vassar Brother's Medical Center
Poughkeepsie, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
The Heart Hospital - Baylor Plano
Plano, Texas, United States
Dixie Regional Medical Center Intermountain
St. George, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Charleston Medical Center
Charleston, West Virginia, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
Chermside West, , Australia
Monash Hospital
Clayton, , Australia
Austin Hospital
Heidelberg, , Australia
Fiona Stanley Hospital
Murdoch, , Australia
John Hunter Hospital
Newcastle, , Australia
Saint Vincents Hospital Sydney
Sydney, , Australia
ZNA Middelheim
Antwerp, , Belgium
St Jan Hospital
Bruges, , Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Laval University Institute of Cardiology and Respirology of Quebec
Québec, Quebec, Canada
Hôpitaux Universitaires - Hôpital Henri Mondor
Créteil, , France
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, , France
Universitätsklinikum Ulm
Ulm, , Germany
Mater Private Hospital
Dublin, , Ireland
Galway University Hospitals - University Hospital Galway (UHG)
Galway, , Ireland
Shaare Zedek Medical Center
Jerusalem, , Israel
Fondazione Poliambulanza
Brescia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Hospital Universitario Central de Asturas
Oviedo, , Spain
Akademiska Sjukhuset
Uppsala, , Sweden
Royal Victoria Hospital - Belfast Health and Social Care Trust
Belfast, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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References
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Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):558-570. doi: 10.1016/j.jcin.2023.01.016.
Provided Documents
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Document Type: Study Protocol: Version 3.0
Document Type: Study Protocol: Version 4.0
Document Type: Study Protocol: Version 5.0
Document Type: Study Protocol: Version 6.0
Document Type: Study Protocol: FX Addendum Version 1.0
Document Type: Study Protocol: FX Addendum Version 2.0
Document Type: Study Protocol: FX Addendum Version 3.0
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT18051EVR008
Identifier Type: -
Identifier Source: org_study_id