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Trial record 1 of 1 for:    NCT04091048
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Optimize PRO Study

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ClinicalTrials.gov Identifier: NCT04091048
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date September 12, 2019
First Posted Date September 16, 2019
Last Update Posted Date May 14, 2020
Actual Study Start Date September 16, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2019)
All-cause mortality or all-stroke at 30 days. [ Time Frame: 30 days post procedure ]
All-cause mortality or all-stroke at 30 days.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 13, 2019)
  • Median days from index procedure to discharge [ Time Frame: Through discharge up to 7 days post index procedure. ]
    Median days from index procedure to discharge
  • AR [ Time Frame: Through discharge up to 7 days post index procedure. ]
    Percentage of subjects with ≥ moderate aortic regurgitation (AR) at discharge
  • Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days [ Time Frame: 30 days ]
    Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 13, 2019)
  • Hospital re-admission rates [ Time Frame: 30-day and 1-year ]
    30-day and 1-year hospital re-admission rates
  • All-cause mortality or all-stroke [ Time Frame: 1-year ]
    1-year composite of all-cause mortality or all-stroke
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Optimize PRO Study
Official Title Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
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 using the Evolut™ PRO and Evolut™ PRO+ device.
Detailed Description This is a post market, multi-center, prospective, non-randomized study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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+ system in accordance with Instructions for Use and local regulations.
Condition Symptomatic Aortic Stenosis
Intervention Device: Evolut™ PRO and Evolut™ PRO+ System
Aortic valve replacement
Study Groups/Cohorts Primary Cohort
Intervention: Device: Evolut™ PRO and Evolut™ PRO+ System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system 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+ system in accordance with the Instructions for Use
  • Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ system;
  • Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to enrollment;
  • Reduced ventricular function with left ventricular ejection fraction (LVEF) <35% as measured by resting echocardiogram;
  • Previous aortic valve replacement;
  • 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 or 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Amy Corrigan 763-514-4000 rs.optimizedpro@medtronic.com
Contact: Yanping Chang 763-514-4000 rs.optimizedpro@medtronic.com
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04091048
Other Study ID Numbers MDT18051EVR008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medtronic Cardiovascular
Study Sponsor Medtronic Cardiovascular
Collaborators Not Provided
Investigators
Principal Investigator: Steven Yakubov, MD OhioHealth
Principal Investigator: Kendra Grubb, MD Emory University
Study Chair: Josep Rodés-Cabau, MD Laval University
Study Chair: Suneet Mittal, MD Valley Health System
Study Chair: Tamim Nazif, MD Columbia - New York Presbyterian
Study Chair: Hemal Gada, MD UPMC Pinnacle
PRS Account Medtronic Cardiovascular
Verification Date May 2020