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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04091048




Registration number
NCT04091048
Ethics application status
Date submitted
12/09/2019
Date registered
16/09/2019

Titles & IDs
Public title
Optimize PRO Study
Scientific title
Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Secondary ID [1] 0 0
MDT18051EVR008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

Primary Cohort -


Treatment: Devices: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Aortic valve replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality or all-stroke
Timepoint [1] 0 0
30 days post procedure
Secondary outcome [1] 0 0
Length of Stay
Timepoint [1] 0 0
Through discharge up to 7 days post index procedure.
Secondary outcome [2] 0 0
AR
Timepoint [2] 0 0
Through discharge up to 7 days post index procedure.
Secondary outcome [3] 0 0
Pacemaker Implantation or Worsening Conduction Disturbance
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Depth of Implant (Evolut FX Only)
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Canting (Evolut FX Addendum Only)
Timepoint [5] 0 0
30 Days

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Saint Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside West
Recruitment hospital [3] 0 0
Monash Hospital - Clayton
Recruitment hospital [4] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [7] 0 0
Saint Vincents Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
- Chermside West
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment postcode(s) [6] 0 0
- Newcastle
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Maryland
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United States of America
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Michigan
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Minnesota
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Montana
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Nebraska
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United States of America
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New Jersey
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New York
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Ohio
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Pennsylvania
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Texas
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Utah
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Virginia
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West Virginia
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United States of America
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Wisconsin
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Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Belgium
State/province [22] 0 0
Brugge
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Créteil
Country [26] 0 0
France
State/province [26] 0 0
Pessac
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Germany
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Ulm
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Ireland
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Dublin
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Ireland
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Galway
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Israel
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Jerusalem
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Italy
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Brescia
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Italy
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Roma
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Spain
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Oviedo
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Sweden
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Uppsala
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United Kingdom
State/province [35] 0 0
Belfast
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiovascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Yakubov, MD
Address 0 0
OhioHealth
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04091048