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

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ClinicalTrials.gov Identifier: NCT04889872
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Aortic Stenosis, Calcific Aortic Valve Stenosis Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2037

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TAVR
Transcatheter Aortic Valve Replacement (TAVR)
 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
No Intervention: CS
Clinical Surveillance (CS)


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 2 years ]
    Non-hierarchical composite of death, and heart failure hospitalization or event

  2. Primary Safety Endpoint [ Time Frame: 30 days ]
    Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention


Secondary Outcome Measures :
  1. Death, stroke, or unplanned cardiovascular hospitalization [ Time Frame: 2 years ]
    The number of patients that had this event

  2. Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 2 years ]
    The number of patients that met all these criteria

  3. Unplanned cardiovascular hospitalization [ Time Frame: 2 years ]
    The number of patients that had this event

  4. Left ventricle (LV) mass index [ Time Frame: 2 years ]
    Echocardiographic measurement of the size of the left ventricle

  5. Stroke volume index [ Time Frame: 2 years ]
    Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.

  6. Diastolic dysfunction ≥ Grade 2 [ Time Frame: 2 years ]
    Echocardiographic measurement of the stiffness of the left ventricle.

  7. N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) [ Time Frame: 2 years ]
    NT-ProBNP is a hormone that measures heart failure. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable.

  8. KCCQ overall score [ Time Frame: 2 years ]
    Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  9. Reduction in LVEF ≥ 5% from baseline AND LVEF < 60% [ Time Frame: 2 years ]
    The number of patients that meet these criteria

  10. New onset atrial fibrillation [ Time Frame: 2 years ]
    The number of patients that develop this condition


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion 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.

Key Exclusion Criteria:

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889872


Contacts
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Contact: Edwards THV Clinical Affairs 949-250-2500 THV_CT.gov@Edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Philippe Généreux, MD Morristown Medical Center, Morristown, NJ, USA
Principal Investigator: Jeroen J Bax, MD, PhD Leiden University Medical Center, Leiden, The Netherlands
Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA, USA
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04889872    
Other Study ID Numbers: 2021-01
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Edwards Lifesciences:
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:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction