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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

Tracking Information
First Submitted Date  ICMJE May 12, 2021
First Posted Date  ICMJE May 17, 2021
Last Update Posted Date April 29, 2024
Actual Study Start Date  ICMJE October 12, 2021
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2023)
  • Primary Effectiveness Endpoint [ Time Frame: 2 years ]
    Non-hierarchical composite of death, and heart failure hospitalization or event
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2021)		 A composite of death, stroke, unplanned cardiovascular hospitalization [ Time Frame: 2 years ]
Number of patients that had one of these events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2023)
  • Death, stroke, or unplanned cardiovascular hospitalization [ Time Frame: 2 years ]
    The number of patients that had this event
  • 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
  • Unplanned cardiovascular hospitalization [ Time Frame: 2 years ]
    The number of patients that had this event
  • Left ventricle (LV) mass index [ Time Frame: 2 years ]
    Echocardiographic measurement of the size of the left ventricle
  • Stroke volume index [ Time Frame: 2 years ]
    Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
  • Diastolic dysfunction ≥ Grade 2 [ Time Frame: 2 years ]
    Echocardiographic measurement of the stiffness of the left ventricle.
  • 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.
  • 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.
  • Reduction in LVEF ≥ 5% from baseline AND LVEF < 60% [ Time Frame: 2 years ]
    The number of patients that meet these criteria
  • New onset atrial fibrillation [ Time Frame: 2 years ]
    The number of patients that develop this condition
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Official Title  ICMJE The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Stenosis, Calcific
  • Aortic Valve Stenosis
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: TAVR
    Transcatheter Aortic Valve Replacement (TAVR)
    Intervention: Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
  • No Intervention: CS
    Clinical Surveillance (CS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2024)		 2250
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2021)		 750
Estimated Study Completion Date  ICMJE June 2037
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwards THV Clinical Affairs 949-250-2500 THV_CT.gov@Edwards.com
Listed Location Countries  ICMJE Australia,   Canada,   Japan,   Netherlands,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04889872
Other Study ID Numbers  ICMJE 2021-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Edwards Lifesciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Edwards Lifesciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Edwards Lifesciences
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP