Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
650 participants
INTERVENTIONAL
2022-04-27
2034-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy
Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
Clinical site determined guideline-directed management and therapy (GDMT) alone
Clinical site determined guideline-directed management and therapy (GDMT) alone
No interventions assigned to this group
Interventions
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Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
Eligibility Criteria
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Inclusion Criteria
* AVA \>1.0 cm² and \<1.5cm²; or
* AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or
* AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²:
and
* Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or
* Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg
Any of the following at-risk features:
* Symptoms of AS, defined as:
* NYHA ≥ Class II, or
* Reduced functional capacity, defined as
* 6MWT \< 300 meters, or
* \< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
* Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
* NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
* Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
* Elevated aortic valve calcium score (\>1200 AU for females and \> 2000 AU for males) as assessed by the MDCT core lab, or
* Any of the following by the qualifying TTE as assessed by the ECL:
* Global longitudinal strain ≤16% (absolute value), or
* E/e' ≥ 14.0 (average of medial and lateral velocities), or
* Diastolic dysfunction ≥ Grade II, or
* LVEF \< 60%
* Stroke Volume Index \< 35 ml/m²
* Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
* The subject and the treating physician agree the subject will return for all required follow-up visits
Exclusion Criteria
* LVEF ≤ 20% by 2-D echo
* Class I indication for cardiac surgery
* Contraindication for placement of a bioprosthetic valve
* Documented history of cardiac amyloidosis
65 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Sorajja, MD
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Josep Rodes-Cabau, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation IUCPQ
Stephan Windecker, Prof.
Role: PRINCIPAL_INVESTIGATOR
Inselspital, Universitätsspital Bern
Locations
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Abrazo Arizone Heart Hospital
Phoenix, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Saint Vincents Medical Center
Bridgeport, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
Saint Vincent's Medical Center Riverside
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Jewish Hospital
Louisville, Kentucky, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, United States
Northwell Health
Manhasset, New York, United States
The Mount Sinai Hospital
New York, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Wake Forest University Heatlh Sciences
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Kettering Health Main Campus
Kettering, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Lehigh Valley Hospital, Inc
Allentown, Pennsylvania, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Medical City Dallas
Dallas, Texas, United States
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Hospital San Antonio
San Antonio, Texas, United States
Intermountain Cardiovascular and Thoracic Surgery
Salt Lake City, Utah, United States
The University of Vermont
Burlington, Vermont, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, United States
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, , Australia
University Hospital Sankt Poelten
Sankt Pölten, , Austria
Allgemeines Krankenhaus - Universitätskliniken Wien
Vienna, , Austria
CHU de Liege- Hopital du Sart Tilman
Liège, , Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Heart Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
CHU de Rennes - Hôpital Pontchaillou
Rennes, Brittany Region, France
CHRU Brest - Hôpital de la Cavale Blanche
Brest, , France
Institut Mutualiste Montsouris
Paris, , France
Hôpital Européen Georges Pompidou
Paris, , France
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund
Dortmund, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinikum der Universität München - Campus Grosshadern
München, , Germany
Galway University Hospitals - University Hospital Galway (UHG)
Galway, , Ireland
Shaare Zedek Medical Center
Jerusalem, , Israel
Rabin Medical Center- Beilinson Hospital
Petah Tikva, , Israel
Presidio Ospedaliero Gaspare Rodolico
Catania, , Italy
Ospedale San Raffaele - Milano
Milan, , Italy
IRCCS Policlinico San Donato
San Donato Milanese, , Italy
Shonan Kamakura General Hospital
Kanagawa, Kamakura, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Kawasaki Saiwai Hospital
Kawasaki, Kanagawa, Japan
Osaka Keisatsu Hospital
Osaka, , Japan
Osaka University Hospital
Osaka, , Japan
Catharina Ziekenhuis
Eindhoven, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Hospital Universitari Clínic de Barcelona
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Skanes Universitetssjukhus
Lund, , Sweden
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Saint Bartholomew's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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D00411092
Identifier Type: -
Identifier Source: org_study_id