RECRUITING

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

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Conditions

Aortic Stenosis, CalcificAortic Valve StenosisTranscatheter aortic valve replacement (TAVR)SAPIEN 3SAPIEN 3 UltraSAPIEN 3 Ultra RESILIAModerate aortic stenosisAortic stenosisTranscatheter heart valve

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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

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Official Title

The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2021-10-12
Study Completion:2037-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04889872

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. 1. 65 years of age or older at time of randomization
  2. 2. Moderate aortic stenosis
  3. 3. Subject has symptoms or evidence of cardiac damage/dysfunction
  4. 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
  1. 1. Native aortic annulus size unsuitable for the THV
  2. 2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
  3. 3. Aortic valve is unicuspid or non-calcified
  4. 4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
  5. 5. Pre-existing mechanical or bioprosthetic aortic valve
  6. 6. Severe aortic regurgitation
  7. 7. Prior balloon aortic valvuloplasty to treat severe AS
  8. 8. LVEF \< 20%
  9. 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
  10. 10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  11. 11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs
CONTACT
949-250-2500
THV_CT.gov@Edwards.com

Principal Investigator

Philippe Généreux, MD
PRINCIPAL_INVESTIGATOR
Morristown Medical Center, Morristown, NJ, USA
Jeroen J Bax, MD, PhD
PRINCIPAL_INVESTIGATOR
Leiden University Medical Center, Leiden, The Netherlands
Raj Makkar, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center, Los Angeles, CA, USA

Study Locations (Sites)

Heart Center LLC, Huntsville
Huntsville, Alabama, 35801
United States
Tucson Medical Center
Tucson, Arizona, 85712
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Huntington Hospital
Pasadena, California, 91105
United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270
United States
Bay Area Structural Heart at Sutter Health
San Francisco, California, 94109
United States
Kaiser San Francisco Medical Center
San Francisco, California, 94118
United States
University of California San Francisco
San Francisco, California, 94143
United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
United States
Stanford Univeristy
Stanford, California, 94305
United States
UC Health Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Yale Universtiy
New Haven, Connecticut, 06510
United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, 32605
United States
Baptist Health Research Center
Jacksonville, Florida, 32207
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
Emory University Atlanta
Atlanta, Georgia, 30308
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Saint Alphonsus
Boise, Idaho, 83704
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Alexian Brothers Hospital
Lisle, Illinois, 60532
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
Louisiana State University
New Orleans, Louisiana, 70112
United States
Ochsner Clinical Foundation
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital Boston
Boston, Massachusetts, 02114
United States
Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota, 55102
United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111
United States
St. Patrick Hospital
Missoula, Montana, 59802
United States
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 03756
United States
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey, 07960
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
United States
The Valley Hospital
Ridgewood, New Jersey, 07450
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
University of Buffalo Kaleida Health
Buffalo, New York, 14203
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
NYU Langone Health
New York, New York, 10016
United States
Columbia University Irving Medical Center/NYPH
New York, New York, 10032
United States
Rochester General Hospital
Rochester, New York, 14621
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Mount Carmel Health System
Columbus, Ohio, 43213
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
Kaiser Permanente Northwest
Clackamas, Oregon, 97015
United States
Providence Heart & Vascular Institute Portland
Portland, Oregon, 97225
United States
Legacy Emanuel Medical Center
Portland, Oregon, 97227
United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213
United States
Pinnacle Health Harrisburg
Wormleysburg, Pennsylvania, 17043
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Baptist Memorial Hospital Memphis
Germantown, Tennessee, 38138
United States
Methodist Le Bonheur Healthcare
Germantown, Tennessee, 38138
United States
Parkwest Medical Center
Knoxville, Tennessee, 37923
United States
Saint Thomas Health
Nashville, Tennessee, 37205
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Ascension Texas Cardiovascular
Austin, Texas, 78705
United States
UT Southwestern Medical Center
Dallas, Texas, 75235
United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
United States
The University of Texas Health Science Center
Houston, Texas, 77030
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
Methodist Hospital of San Antonio
San Antonio, Texas, 78229
United States
Kaiser Mid Atlantic
McLean, Virginia, 22102
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Swedish Medical Center
Seattle, Washington, 98112
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Philippe Généreux, MD, PRINCIPAL_INVESTIGATOR, Morristown Medical Center, Morristown, NJ, USA
  • Jeroen J Bax, MD, PhD, PRINCIPAL_INVESTIGATOR, Leiden University Medical Center, Leiden, The Netherlands
  • Raj Makkar, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center, Los Angeles, CA, USA

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 Date2021-10-12
Study Completion Date2037-06

Study Record Updates

Study Start Date2021-10-12
Study Completion Date2037-06

Terms related to this study

Keywords Provided by Researchers

  • Transcatheter aortic valve replacement (TAVR)
  • SAPIEN 3
  • SAPIEN 3 Ultra
  • SAPIEN 3 Ultra RESILIA
  • Moderate aortic stenosis
  • Aortic stenosis
  • Transcatheter heart valve

Additional Relevant MeSH Terms

  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis