Status:
COMPLETED
Optimize PRO Study
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Symptomatic Aortic Stenosis
Eligibility:
All Genders
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 whi...
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
- 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
- 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.
Key Trial Info
Start Date :
September 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
1127 Patients enrolled
Trial Details
Trial ID
NCT04091048
Start Date
September 16 2019
End Date
November 13 2024
Last Update
November 13 2025
Active Locations (60)
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1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35233
2
California Pacific Medical Center - Sutter Health
San Francisco, California, United States, 94109
3
Hartford Hospital
Hartford, Connecticut, United States, 06102
4
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510