Optimize PRO Study

Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Katie Flor; Phone Number: 262-693-6127; Email: Katie.j.Flor@medtronic.com
• Study Contact Backup: Name: Karim Yafi; Phone Number: 61(0)481033178; Email: Karim.el.yafi@medtronic.com

Study Locations

• Australia
  • Chermside West, Australia
    • The Prince Charles Hospital
  • Clayton, Australia
    • Monash Hospital
  • Heidelberg, Australia
    • Austin Hospital
  • Murdoch, Australia
    • Fiona Stanley Hospital
  • Newcastle, Australia
    • John Hunter Hospital
  • Sydney, Australia
    • Saint Vincents Hospital Sydney
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Saint Vincents Hospital Sydney
• Belgium
  • Antwerpen, Belgium
    • ZNA Middelheim
  • Brugge, Belgium
    • St Jan Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Laval University Institute of Cardiology and Respirology of Quebec
• France
  • Créteil, France
    • Hôpitaux Universitaires - Hôpital Henri Mondor
  • Pessac, France
    • Hôpital Haut-Lévêque - CHU de Bordeaux
• Germany
  • Ulm, Germany
    • Universitatsklinikum Ulm
• Ireland
  • Dublin, Ireland
    • Mater Private Hospital
  • Galway, Ireland
    • Galway University Hospitals - University Hospital Galway (UHG)
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
• Italy
  • Brescia, Italy
    • Fondazione Poliambulanza
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli
• Spain
  • Oviedo, Spain
    • Hospital Universitario Central de Asturas
• Sweden
  • Uppsala, Sweden
    • Akademiska Sjukhuset
• United Kingdom
  • Belfast, United Kingdom
    • Royal Victoria Hospital - Belfast Health and Social Care Trust
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama At Birmingham Hospital
  • California
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Sutter Health
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
    • Norwalk, Connecticut, United States, 06851
      • St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital/Prarie Education and Research Cooperative
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital (Minneapolis Heart)
  • Montana
    • Missoula, Montana, United States, 59802
      • Providence St. Patrick Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian - Columbia University Medical Center
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brother's Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital - Cedar Crest
    • Harrisburg, Pennsylvania, United States, 17101
      • UPMC Pinnacle Harrisburg
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital - Baylor Plano
  • Utah
    • Saint George, Utah, United States, 84770
      • Dixie Regional Medical Center Intermountain
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53125
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality or all-stroke	All-cause mortality or all-stroke at 30 days.	30 days post procedure

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital re-admission rates	30-day and 1-year hospital re-admission rates	30-day and 1-year
All-cause mortality or all-stroke	1-year composite of all-cause mortality or all-stroke	1-year

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Kendra Grubb, MD, Emory University; Principal Investigator: Steven Yakubov, MD, OhioHealth; 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

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): December 15, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MDT18051EVR008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes