Optimize PRO Study

NCT04091048 | Completed Results FDA Device

• 1 other identifier: MDT18051EVR008
• Study Type: observational
• Target: 1,127
• Locations: 12 countries
• Sites: 60

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.

Conditions

Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality or All-stroke

  All-cause mortality or all-stroke at 30 days.

  30 days post procedure

Secondary Outcomes (5)

• Length of Stay

  Through discharge up to 7 days post index procedure.

• Aortic Regurgitation (AR)

  Through discharge up to 7 days post index procedure.

• Pacemaker Implantation or Worsening Conduction Disturbance

  30 days

• Depth of Implant (Evolut FX Only)

  30 days

• Canting (Evolut FX Addendum Only)

  30 Days

Study Arms (1)

Primary Cohort

Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

Interventions

Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) DEVICE

Aortic valve replacement

Primary Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (60)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35233, United States

Location

California Pacific Medical Center - Sutter Health

San Francisco, California, 94109, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.

Norwalk, Connecticut, 06851, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

St. John's Hospital/Prarie Education and Research Cooperative

Springfield, Illinois, 62769, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern Hospital (Minneapolis Heart)

Minneapolis, Minnesota, 55407, United States

Location

Providence St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York Presbyterian - Columbia University Medical Center

New York, New York, 10032, United States

Location

Vassar Brother's Medical Center

Poughkeepsie, New York, 12601, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The Heart Hospital - Baylor Plano

Plano, Texas, 75093, United States

Location

Dixie Regional Medical Center Intermountain

St. George, Utah, 84770, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Charleston Medical Center

Charleston, West Virginia, 25304, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53125, United States

Location

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Chermside West, Australia

Location

Monash Hospital

Clayton, Australia

Location

Austin Hospital

Heidelberg, Australia

Location

Fiona Stanley Hospital

Murdoch, Australia

Location

John Hunter Hospital

Newcastle, Australia

Location

Saint Vincents Hospital Sydney

Sydney, Australia

Location

ZNA Middelheim

Antwerp, Belgium

Location

St Jan Hospital

Bruges, Belgium

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Laval University Institute of Cardiology and Respirology of Quebec

Québec, Quebec, G1V 4G5, Canada

Location

Hôpitaux Universitaires - Hôpital Henri Mondor

Créteil, France

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, France

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Mater Private Hospital

Dublin, Ireland

Location

Galway University Hospitals - University Hospital Galway (UHG)

Galway, Ireland

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Fondazione Poliambulanza

Brescia, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Hospital Universitario Central de Asturas

Oviedo, Spain

Location

Akademiska Sjukhuset

Uppsala, Sweden

Location

Royal Victoria Hospital - Belfast Health and Social Care Trust

Belfast, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Related Publications (1)

• Grubb KJ, Gada H, Mittal S, Nazif T, Rodes-Cabau J, Fraser DGW, Lin L, Rovin JD, Khalil R, Sultan I, Gardner B, Lorenz D, Chetcuti SJ, Patel NC, Harvey JE, Mahoney P, Schwartz B, Jafar Z, Wang J, Potluri S, Vora AN, Sanchez C, Corrigan A, Li S, Yakubov SJ. Clinical Impact of Standardized TAVR Technique and Care Pathway: Insights From the Optimize PRO Study. JACC Cardiovasc Interv. 2023 Mar 13;16(5):558-570. doi: 10.1016/j.jcin.2023.01.016.

  PMID: 36922042 DERIVED

Results Point of Contact

• Title: Katie Flor, Clinical Research Manager
• Organization: Medtronic Cardiovascular

katie.j.flor@medtronic.com

262 693 6127

Study Officials

• Steven Yakubov, MD

  OhioHealth

  PRINCIPAL INVESTIGATOR

• Kendra Grubb, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 16, 2019
• Primary Completion: December 15, 2023
• Study Completion: November 13, 2024
• Last Updated: January 13, 2026
• Results First Posted: February 6, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); AU (7); CA (2); DE (1); IE (2); BE (2); US (37); IT (2); GB (2); IL (1); FR (2); ES (1)