Clinical trial NCT04091048: Optimize PRO Study
Official title: Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Aortic Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 1127
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with symptomatic native aortic valve stenosis that necessitates valve replacement who meet the criteria for on-label use of the Evolut™ PRO or Evolut™ PRO+ (and FX system for the addendum where applicable) system in accordance with Instructions for Use and local regulations.

Brief summary: The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.

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: This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study.

The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.

Eligibility criteria: Inclusion Criteria:

* Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations;
* 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:

* Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable) in accordance with the Instructions for Use
* 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.

Primary outcomes:
measure: All-cause Mortality or All-stroke
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Length of Stay
timeFrame: Through discharge up to 7 days post index procedure.
measure: Aortic Regurgitation (AR)
timeFrame: Through discharge up to 7 days post index procedure.
measure: Pacemaker Implantation or Worsening Conduction Disturbance
timeFrame: 30 days
measure: Depth of Implant (Evolut FX Only)
timeFrame: 30 days
measure: Canting (Evolut FX Addendum Only)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospital
state: Alabama
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Health
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Norwalk
country: United States
facility: St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital/Prarie Education and Research Cooperative
state: Illinois
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital (Minneapolis Heart)
state: Minnesota
city: Missoula
country: United States
facility: Providence St. Patrick Hospital
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian - Columbia University Medical Center
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brother's Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital - Baylor Plano
state: Texas
city: Saint George
country: United States
facility: Dixie Regional Medical Center Intermountain
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Charleston
country: United States
facility: Charleston Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Darlinghurst
country: Australia
facility: Saint Vincents Hospital Sydney
state: New South Wales
city: Chermside West
country: Australia
facility: The Prince Charles Hospital
city: Clayton
country: Australia
facility: Monash Hospital
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Newcastle
country: Australia
facility: John Hunter Hospital
city: Sydney
country: Australia
facility: Saint Vincents Hospital Sydney
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: St Jan Hospital
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Québec
country: Canada
facility: Laval University Institute of Cardiology and Respirology of Quebec
state: Quebec
city: Créteil
country: France
facility: Hôpitaux Universitaires - Hôpital Henri Mondor
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Dublin
country: Ireland
facility: Mater Private Hospital
city: Galway
country: Ireland
facility: Galway University Hospitals - University Hospital Galway (UHG)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Brescia
country: Italy
facility: Fondazione Poliambulanza
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturas
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital - Belfast Health and Social Care Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
Study officials:
affiliation: OhioHealth
name: Steven Yakubov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Kendra Grubb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Josep Rodés-Cabau, MD
role: STUDY_CHAIR
affiliation: Valley Health System
name: Suneet Mittal, MD
role: STUDY_CHAIR
affiliation: Columbia - New York Presbyterian
name: Tamim Nazif, MD
role: STUDY_CHAIR
affiliation: UPMC Pinnacle
name: Hemal Gada, MD
role: STUDY_CHAIR
affiliation: Manchester Royal Infirmary
name: Douglas Fraser, MD
role: STUDY_CHAIR
References: