Symptomatic Aortic StenosisNCT04091048
Optimize PRO Study
An observational study of Symptomatic Aortic Stenosis, run by Medtronic Cardiovascular at 60 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Type of treatment
- Medical device
- How many people
- 1,127 participants
- Where
- 60 sitesin 12 countries
- Study dates
- 16 Sep 2019to 13 Nov 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
60 sites in 12 countries.
60 sites in 12 countries
United States37 sites
Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18103
University of Michigan
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30308
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35233
Buffalo General Medical Center
Buffalo, New York, 14203
Charleston Medical Center
Charleston, West Virginia, 25304
Rush University Medical Center
Chicago, Illinois, 60612
Morton Plant Hospital
Clearwater, Florida, 33756
Ohio Health Research Institute
Columbus, Ohio, 43214
Ascension St. John Hospital
Detroit, Michigan, 48236
Spectrum Health
Grand Rapids, Michigan, 49503
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, 17101
Hartford Hospital
Hartford, Connecticut, 06102
Houston Methodist Hospital
Houston, Texas, 77030
Kettering Medical Center
Kettering, Ohio, 45429
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53125
Abbott Northwestern Hospital (Minneapolis Heart)
Minneapolis, Minnesota, 55407
Providence St. Patrick Hospital
Missoula, Montana, 59802
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Yale New Haven Hospital
New Haven, Connecticut, 06510
The Mount Sinai Hospital
New York, New York, 10029
New York Presbyterian - Columbia University Medical Center
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut, 06851
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
The Heart Hospital - Baylor Plano
Plano, Texas, 75093
Vassar Brother's Medical Center
Poughkeepsie, New York, 12601
The Valley Hospital
Ridgewood, New Jersey, 07450
St. Francis Hospital
Roslyn, New York, 11576
California Pacific Medical Center - Sutter Health
San Francisco, California, 94109
St. John's Hospital/Prarie Education and Research Cooperative
Springfield, Illinois, 62769
Dixie Regional Medical Center Intermountain
St. George, Utah, 84770
Stony Brook University Hospital
Stony Brook, New York, 11794
York Hospital
York, Pennsylvania, 17403
Australia7 sites
The Prince Charles Hospital
Chermside West
Monash Hospital
Clayton
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010
Austin Hospital
Heidelberg
Fiona Stanley Hospital
Murdoch
John Hunter Hospital
Newcastle
Saint Vincents Hospital Sydney
Sydney
Canada2 sites
Laval University Institute of Cardiology and Respirology of Quebec
Québec, Quebec, G1V 4G5
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
France2 sites
Hôpitaux Universitaires - Hôpital Henri Mondor
Créteil
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac
Ireland2 sites
Mater Private Hospital
Dublin
Galway University Hospitals - University Hospital Galway (UHG)
Galway
Italy2 sites
Fondazione Poliambulanza
Brescia
Fondazione Policlinico Universitario Agostino Gemelli
Roma
United Kingdom2 sites
Royal Victoria Hospital - Belfast Health and Social Care Trust
Belfast
Manchester Royal Infirmary
Manchester
About this study
Official title: 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.
Read the 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.
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)Device
Aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort | Not described Receives: Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality or All-stroke
All-cause mortality or all-stroke at 30 days.
Measured: 30 days post procedure
Secondary outcomes (5)
Length of Stay
Median days from index procedure to discharge
Measured: Through discharge up to 7 days post index procedure.
Aortic Regurgitation (AR)
Percentage of subjects with ≥ moderate AR at discharge
Measured: 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
Measured: 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)
Measured: 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)
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start16 Sep 2019
- Primary completion15 Dec 2023
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Yakubov, MD, Principal investigator, OhioHealthKendra Grubb, MD, Principal investigator, Emory UniversityJosep Rodés-Cabau, MD, Study chair, Laval UniversitySuneet Mittal, MD, Study chair, Valley Health SystemTamim Nazif, MD, Study chair, Columbia - New York PresbyterianHemal Gada, MD, Study chair, UPMC PinnacleDouglas Fraser, MD, Study chair, Manchester Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091048
- Sponsor's protocol ID
- MDT18051EVR008
- Status last verified
- Dec 2025
- First submitted
- 12 Sep 2019
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dvir D, Jilaihawi HA, Fraser D, Rodes-Cabau J, Nazif T, Mittal S, Grubb KJ, Gada H, Teiger E, Lin L, Rovin JD, Khalil RF, Sultan I, Yudi MB, Gardner B, Lorenz D, Chetcuti S, Patel NC, Harvey J, Mahoney P, Talreja D, Trani C, Mylotte D, Schwartz B, Jafar Z, Van der Heyden J, Maffeo D, Yong G, Valle-Fernandez RD, Wang J, Gooley R, Yeh YJ, Yakubov SJ. Core-Laboratory Evaluation of Implantation Depth and Clinical Outcomes in TAVR: Optimize PRO Study. JACC Cardiovasc Interv. 2026 Aug 10;19(15):2025-2039. doi: 10.1016/j.jcin.2026.05.007. Epub 2026 May 21.
PubMed 42223923Grubb 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.
PubMed 36922042