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Recruiting NCT04889872

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

No phase Interventional Aortic Stenosis, Calcific Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA.
Who it may be relevant to
Registry conditions: Aortic Stenosis, Calcific, Aortic Valve Stenosis. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Japan, Netherlands +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Detailed description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Interventions

  • Device SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
    Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Primary outcome measures

  • Primary Effectiveness Endpoint [Time frame: 2 years]
  • Primary Safety Endpoint [Time frame: 30 days]
Secondary outcome measures (5)
  • Death, stroke, or heart failure hospitalization [Time frame: 2 years]
  • Alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score improvement ≥10 points from baseline sustained through 2 years [Time frame: 2 years]
  • Heart failure hospitalization [Time frame: 2 years]
  • Left ventricle (LV) mass index [Time frame: 2 years]
  • Diastolic dysfunction ≥ Grade 2 [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 65 years of age or older at time of randomization
  • Moderate aortic stenosis
  • Subject has symptoms or evidence of cardiac damage/dysfunction
  • 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.

Exclusion criteria

  • Native aortic annulus size unsuitable for the THV
  • Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
  • Aortic valve is unicuspid or non-calcified
  • Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
  • Pre-existing mechanical or bioprosthetic aortic valve
  • Severe aortic regurgitation
  • Prior balloon aortic valvuloplasty to treat severe AS
  • LVEF < 20%
  • Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
  • Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  • Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 65 centers
  • Heart Center LLC, Huntsville — Huntsville
  • Tucson Medical Center — Tucson
  • Cedars-Sinai Medical Center — Los Angeles
  • Huntington Hospital — Pasadena
  • Eisenhower Desert Cardiology Center — Rancho Mirage
  • Bay Area Structural Heart at Sutter Health — San Francisco
  • Kaiser San Francisco Medical Center — San Francisco
  • University of California San Francisco — San Francisco
  • … and 57 more centers
Australia · 4 centers
  • The Prince Charles Hospital — Chermside
  • Royal Adelaide Hospital — Adelaide
  • Flinders Medical Centre — Bedford Park
  • Monash Health — Clayton
Japan · 4 centers
  • Kokura Memorial Hospital — Fukuoka
  • Sendai Kousei Hospital — Sendai
  • Sakakibara Heart Institute — Fuchū
  • Keio University Hospital — Shinjuku
Netherlands · 3 centers
  • AMC Amsterdam — Amsterdam
  • Leiden Universitair Medisch Centrum — Leiden
  • Erasmus Rotterdam — Rotterdam
Canada · 2 centers
  • St. Paul's Hospital — Vancouver
  • Hamiton Health Services — Hamilton
Switzerland · 2 centers
  • Hôpitaux Universitaire de Genève — Geneva
  • Universitätsspital Zürich — Zurich

Publications

  • Genereux P, Makkar RR, Bax JJ, Pibarot P, Lindman BR, Prince H, Park B, Cohen DJ, Mack MJ, Leon MB. Design and rationale of the prospective, randomized, controlled trial to assess the management of moderate aortic stenosis by clinical surveillance or transcatheter aortic valve replacement: The PROGRESS Trial. Am Heart J. 2026 Jul;297:107433. doi: 10.1016/j.ahj.2026.107433. Epub 2026 Mar 25. PMID 41895563

Identifiers

NCT: NCT04889872 · 2021-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗