Optimize PRO Study

Symptomatic Aortic Stenosis Clinical Trial

Official title:

Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04091048
• Other study ID #: MDT18051EVR008
• Status: Active, not recruiting
• Start date: September 16, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

Device:
• Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
Aortic valve replacement

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside West
Australia	Monash Hospital	Clayton
Australia	Saint Vincents Hospital Sydney	Darlinghurst	New South Wales
Australia	Austin Hospital	Heidelberg
Australia	Fiona Stanley Hospital	Murdoch
Australia	John Hunter Hospital	Newcastle
Australia	Saint Vincents Hospital Sydney	Sydney
Belgium	ZNA Middelheim	Antwerpen
Belgium	St Jan Hospital	Brugge
Canada	Laval University Institute of Cardiology and Respirology of Quebec	Québec	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
France	Hôpitaux Universitaires - Hôpital Henri Mondor	Créteil
France	Hôpital Haut-Lévêque - CHU de Bordeaux	Pessac
Germany	Universitätsklinikum Ulm	Ulm
Ireland	Mater Private Hospital	Dublin
Ireland	Galway University Hospitals - University Hospital Galway (UHG)	Galway
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Fondazione Poliambulanza	Brescia
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Spain	Hospital Universitario Central de Asturas	Oviedo
Sweden	Akademiska Sjukhuset	Uppsala
United Kingdom	Royal Victoria Hospital - Belfast Health and Social Care Trust	Belfast
United Kingdom	Manchester Royal Infirmary	Manchester
United States	Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	Buffalo General Medical Center	Buffalo	New York
United States	Charleston Medical Center	Charleston	West Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Morton Plant Hospital	Clearwater	Florida
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	UPMC Pinnacle Harrisburg	Harrisburg	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Houston Methodist Hospital	Houston	Texas
United States	Kettering Medical Center	Kettering	Ohio
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital (Minneapolis Heart)	Minneapolis	Minnesota
United States	Providence St. Patrick Hospital	Missoula	Montana
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	New York Presbyterian - Columbia University Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.	Norwalk	Connecticut
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	The Heart Hospital - Baylor Plano	Plano	Texas
United States	Vassar Brother's Medical Center	Poughkeepsie	New York
United States	The Valley Hospital	Ridgewood	New Jersey
United States	St. Francis Hospital	Roslyn	New York
United States	Dixie Regional Medical Center Intermountain	Saint George	Utah
United States	California Pacific Medical Center - Sutter Health	San Francisco	California
United States	St. John's Hospital/Prarie Education and Research Cooperative	Springfield	Illinois
United States	Stony Brook University Hospital	Stony Brook	New York
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Ireland,  Israel,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital re-admission rates	30-day and 1-year hospital re-admission rates	30-day and 1-year
Other	All-cause mortality or all-stroke	1-year composite of all-cause mortality or all-stroke	1-year
Primary	All-cause mortality or all-stroke	All-cause mortality or all-stroke at 30 days.	30 days post procedure
Secondary	Length of Stay	Median days from index procedure to discharge	Through discharge up to 7 days post index procedure.
Secondary	AR	Percentage of subjects with = moderate aortic regurgitation (AR) at discharge	Through discharge up to 7 days post index procedure.
Secondary	Pacemaker Implantation or Worsening Conduction Disturbance	Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days	30 days
Secondary	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
Secondary	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