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Optimize PRO Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091048
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : April 8, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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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.


Condition or disease Intervention/treatment
Symptomatic Aortic Stenosis Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

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 Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Actual Study Start Date : September 16, 2019
Actual Primary Completion Date : December 15, 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Primary Cohort Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Aortic valve replacement


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality or all-stroke [ Time Frame: 30 days post procedure ]
    All-cause mortality or all-stroke at 30 days.


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: Through discharge up to 7 days post index procedure. ]
    Median days from index procedure to discharge

  2. AR [ Time Frame: Through discharge up to 7 days post index procedure. ]
    Percentage of subjects with ≥ moderate aortic regurgitation (AR) at discharge

  3. Pacemaker Implantation or Worsening Conduction Disturbance [ Time Frame: 30 days ]
    Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days

  4. Depth of Implant (Evolut FX Only) [ Time Frame: 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)

  5. Canting (Evolut FX Addendum Only) [ Time Frame: 30 Days ]
    Percentage of subjects with a canting absolute value [NCC- Left Coronary Cusp(LCC)] of ≤ 2.0 mm (Evolut FX Addendum Only)


Other Outcome Measures:
  1. Hospital re-admission rates [ Time Frame: 30-day and 1-year ]
    30-day and 1-year hospital re-admission rates

  2. All-cause mortality or all-stroke [ Time Frame: 1-year ]
    1-year composite of all-cause mortality or all-stroke


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091048


Locations
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Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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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
Study Chair: Douglas Fraser, MD Manchester Royal Infirmary
More Information
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT04091048    
Other Study ID Numbers: MDT18051EVR008
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: April 8, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction