Optimize PRO Study

Completed

Conditions studied: Symptomatic Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT04091048

Run by

Medtronic Cardiovascular

People needed

1127

Starts

2019-09-16

Expected to finish

2024-11-13

Last updated by the study team

2026-01-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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