Optimize PRO Study

Completed

• Conditions: Symptomatic Aortic Stenosis

• Registration Number: NCT04091048
• Lead Sponsor: Medtronic Cardiovascular

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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-13
• Study Start: 2019-09-16
• Study First Posted: 2019-09-16
• Primary Completion: 2023-12-15
• Study Completion: 2024-11-13
• Results First Submitted: 2024-11-25
• Results First Submitted QC: 2025-02-05
• Results First Posted: 2025-02-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause Mortality or All-stroke	30 days post procedure	All-cause mortality or all-stroke at 30 days.

Secondary Outcome Measures

Name	Time	Method
Aortic Regurgitation (AR)	Through discharge up to 7 days post index procedure.	Percentage of subjects with ≥ moderate AR at discharge
Pacemaker Implantation or Worsening Conduction Disturbance	30 days	Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days
Length of Stay	Through discharge up to 7 days post index procedure.	Median days from index procedure to discharge
Depth of Implant (Evolut FX Only)	30 days	Percentage of subjects with a Non-Coronary Cusp (NCC) depth of implant between 1.0 and 5.0 mm (Evolut FX Addendum Only)
Canting (Evolut FX Addendum Only)	30 Days	Percentage of subjects with a canting absolute value \[NCC- Left Coronary Cusp(LCC)\] of ≤ 2.0 mm (Evolut FX Addendum Only)

Trial Locations

Locations (59)

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

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