Evolut™ EXPAND TAVR II Pivotal Trial
- Conditions
- Moderate Aortic Valve Stenosis
- Interventions
- Device: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Registration Number
- NCT05149755
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Detailed Description
Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 650
o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:
- 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
Key
- Age < 65 years
- LVEF ≤ 20% by 2-D echo
- Class I indication for cardiac surgery
- Contraindication for placement of a bioprosthetic valve
- Documented history of cardiac amyloidosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT) Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy
- Primary Outcome Measures
Name Time Method Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention. 30 days Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention. 2 years
- Secondary Outcome Measures
Name Time Method Heart failure hospitalizations or events. 2 years Composite of all-cause mortality and heart failure hospitalizations or events. 2 years Days alive and free of unplanned cardiovascular hospitalizations 2 years All-cause mortality 2 years Unplanned cardiovascular hospitalizations 2 years Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline) 1 year Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations 2 years
Trial Locations
- Locations (99)
Presidio Ospedaliero Gaspare Rodolico
🇮🇹Catania, Italy
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
Ascension Saint John Hospital
🇺🇸Detroit, Michigan, 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, 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
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
🇺🇸Saint 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
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, 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
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, 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 Methosidst 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 Stint 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
🇦🇹Wien, Austria
CHU de Liege- Hopital du Sart Tilman
🇧🇪Liège, Belgium
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Montreal Heart Hospital
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Quebec City, Quebec, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Canada
CHU de Rennes - Hôpital Pontchaillou
🇫🇷Rennes, Brittany, France
CHRU Brest - Hôpital de la Cavale Blanche
🇫🇷Brest, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
🇫🇷Clermont-Ferrand, France
Hôpital de la Timone
🇫🇷Marseille, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
Clinique Pasteur
🇫🇷Toulouse Cedex, 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
Ospedale San Raffaele - Milano
🇮🇹Milano, 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
Royal Victoria Hospital - Belfast Health and Social Care Trust
🇬🇧Belfast, U.k., United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, United Kingdom