ACTIVE_NOT_RECRUITING

Evolut™ EXPAND TAVR II Pivotal Trial

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Conditions

Moderate Aortic Valve StenosisaorticstenosismoderatevalveTAVR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Official Title

Evolut™ EXPAND TAVR II Pivotal Trial

Quick Facts

Study Start:2022-04-27
Study Completion:2034-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05149755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * AVA \>1.0 cm² and \<1.5cm²; or
  2. * AVA ≤ 1.0 cm² with AVAI \> 0.6cm²/m² if BMI \< 30 kg/m²: or
  3. * AVA ≤ 1.0 cm² with AVAI \> 0.5cm²/m² if BMI ≥ 30 kg/m²:
  4. * Max aortic velocity ≥ 3.0 m/sec. and \< 4.0 m/sec. or
  5. * Mean aortic gradient ≥ 20mmHg and \< 40.0 mmHg
  6. * Symptoms of AS, defined as:
  7. * NYHA ≥ Class II, or
  8. * Reduced functional capacity, defined as
  9. * 6MWT \< 300 meters, or
  10. * \< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
  11. * Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
  12. * NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
  13. * Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
  14. * Elevated aortic valve calcium score (\>1200 AU for females and \> 2000 AU for males) as assessed by the MDCT core lab, or
  15. * Any of the following by the qualifying TTE as assessed by the ECL:
  16. * Global longitudinal strain ≤16% (absolute value), or
  17. * E/e' ≥ 14.0 (average of medial and lateral velocities), or
  18. * Diastolic dysfunction ≥ Grade II, or
  19. * LVEF \< 60%
  20. * Stroke Volume Index \< 35 ml/m²
  21. * Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
  22. * The subject and the treating physician agree the subject will return for all required follow-up visits
  1. * Age \< 65 years
  2. * LVEF ≤ 20% by 2-D echo
  3. * Class I indication for cardiac surgery
  4. * Contraindication for placement of a bioprosthetic valve
  5. * Documented history of cardiac amyloidosis

Contacts and Locations

Principal Investigator

Paul Sorajja, MD
PRINCIPAL_INVESTIGATOR
Allina Health System
Josep Rodes-Cabau, MD
PRINCIPAL_INVESTIGATOR
Fondation IUCPQ
Stephan Windecker, Prof.
PRINCIPAL_INVESTIGATOR
Inselspital, Universitätsspital Bern

Study Locations (Sites)

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
United States
Abrazo Arizone Heart Hospital
Phoenix, Arizona, 85016
United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Saint Vincents Medical Center
Bridgeport, Connecticut, 06606-4201
United States
Hartford Hospital
Hartford, Connecticut, 06106
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
University of Florida
Gainesville, Florida, 32608
United States
Saint Vincent's Medical Center Riverside
Jacksonville, Florida, 32204
United States
Orlando Health
Orlando, Florida, 32806
United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308-5054
United States
Tampa General Hospital
Tampa, Florida, 33620
United States
Jewish Hospital
Louisville, Kentucky, 40202
United States
Terrebonne General Medical Center
Houma, Louisiana, 70360
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109-1274
United States
Ascension Saint John Hospital
Detroit, Michigan, 48236
United States
Spectrum Health
Grand Rapids, Michigan, 49503
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
United States
Catholic Medical Center
Manchester, New Hampshire, 03102
United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
United States
Englewood Hospital & Medical Center
Englewood, New Jersey, 076931
United States
Northwell Health
Manhasset, New York, 11030
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
Mission Hospital
Asheville, North Carolina, 28801
United States
Wake Forest University Heatlh Sciences
Winston-Salem, North Carolina, 27157
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Kettering Health Main Campus
Kettering, Ohio, 45429
United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239
United States
Lehigh Valley Hospital, Inc
Allentown, Pennsylvania, 18103
United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403
United States
Medical City Dallas
Dallas, Texas, 75230
United States
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, 76104
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Methodist Hospital San Antonio
San Antonio, Texas, 78229
United States
Intermountain Cardiovascular and Thoracic Surgery
Salt Lake City, Utah, 84111
United States
The University of Vermont
Burlington, Vermont, 05401-1473
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiovascular

  • Paul Sorajja, MD, PRINCIPAL_INVESTIGATOR, Allina Health System
  • Josep Rodes-Cabau, MD, PRINCIPAL_INVESTIGATOR, Fondation IUCPQ
  • Stephan Windecker, Prof., PRINCIPAL_INVESTIGATOR, Inselspital, Universitätsspital Bern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-27
Study Completion Date2034-12

Study Record Updates

Study Start Date2022-04-27
Study Completion Date2034-12

Terms related to this study

Keywords Provided by Researchers

  • aortic
  • stenosis
  • moderate
  • valve
  • TAVR

Additional Relevant MeSH Terms

  • Moderate Aortic Valve Stenosis