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

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.

Conditions

Aortic Stenosis, Calcific, Aortic Valve Stenosis

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Aortic Stenosis, Calcific
Intervention / Treatment

-

Contacts and Locations

Huntsville

Heart Center LLC, Huntsville, Huntsville, Alabama, United States, 35801

Tucson

Tucson Medical Center, Tucson, Arizona, United States, 85712

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Pasadena

Huntington Hospital, Pasadena, California, United States, 91105

Rancho Mirage

Eisenhower Desert Cardiology Center, Rancho Mirage, California, United States, 92270

San Francisco

Bay Area Structural Heart at Sutter Health, San Francisco, California, United States, 94109

San Francisco

Kaiser San Francisco Medical Center, San Francisco, California, United States, 94118

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Santa Barbara

Santa Barbara Cottage Hospital, Santa Barbara, California, United States, 93105

Stanford

Stanford Univeristy, Stanford, California, United States, 94305

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2037-06