Optimize PRO Study
- Conditions
- Symptomatic Aortic Stenosis
- Interventions
- Device: Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Registration Number
- NCT04091048
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1127
- 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.
-
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary Cohort Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum) -
- Primary Outcome Measures
Name Time Method All-cause Mortality or All-stroke 30 days post procedure All-cause mortality or all-stroke at 30 days.
- Secondary Outcome Measures
Name Time Method Aortic Regurgitation (AR) Through discharge up to 7 days post index procedure. Percentage of subjects with ≥ moderate AR at discharge
Pacemaker Implantation or Worsening Conduction Disturbance 30 days Rate of pacemaker implant for new onset or worsening conduction disturbance at 30 days
Length of Stay Through discharge up to 7 days post index procedure. Median days from index procedure to discharge
Depth of Implant (Evolut FX Only) 30 days Percentage of subjects with a Non-Coronary Cusp (NCC) depth of implant between 1.0 and 5.0 mm (Evolut FX Addendum Only)
Canting (Evolut FX Addendum Only) 30 Days Percentage of subjects with a canting absolute value \[NCC- Left Coronary Cusp(LCC)\] of ≤ 2.0 mm (Evolut FX Addendum Only)
Trial Locations
- Locations (59)
St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
🇺🇸Norwalk, Connecticut, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Providence St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
California Pacific Medical Center - Sutter Health
🇺🇸San Francisco, California, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Dixie Regional Medical Center Intermountain
🇺🇸Saint George, Utah, United States
Medstar Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Abbott Northwestern Hospital (Minneapolis Heart)
🇺🇸Minneapolis, Minnesota, United States
New York Presbyterian - Columbia University Medical Center
🇺🇸New York, New York, United States
St. John's Hospital/Prarie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Austin Hospital
🇦🇺Heidelberg, Australia
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
University of Alabama at Birmingham Hospital
🇺🇸Birmingham, Alabama, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
UPMC Pinnacle Harrisburg
🇺🇸Harrisburg, Pennsylvania, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
ZNA Middelheim
🇧🇪Antwerpen, Belgium
Vassar Brother's Medical Center
🇺🇸Poughkeepsie, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
The Heart Hospital - Baylor Plano
🇺🇸Plano, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Saint Vincents Hospital Sydney
🇦🇺Sydney, Australia
Charleston Medical Center
🇺🇸Charleston, West Virginia, United States
The Prince Charles Hospital
🇦🇺Chermside West, Australia
St Jan Hospital
🇧🇪Brugge, Belgium
John Hunter Hospital
🇦🇺Newcastle, Australia
Akademiska Sjukhuset
🇸🇪Uppsala, Sweden
Laval University Institute of Cardiology and Respirology of Quebec
🇨🇦Québec, Quebec, Canada
Hôpitaux Universitaires - Hôpital Henri Mondor
🇫🇷Créteil, France
Hôpital Haut-Lévêque - CHU de Bordeaux
🇫🇷Pessac, France
Monash Hospital
🇦🇺Clayton, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Mater Private Hospital
🇮🇪Dublin, Ireland
Galway University Hospitals - University Hospital Galway (UHG)
🇮🇪Galway, Ireland
Fondazione Poliambulanza
🇮🇹Brescia, Italy
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Hospital Universitario Central de Asturas
🇪🇸Oviedo, Spain
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Royal Victoria Hospital - Belfast Health and Social Care Trust
🇬🇧Belfast, United Kingdom
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States