PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04889872|
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : January 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis, Calcific Aortic Valve Stenosis||Device: SAPIEN 3 / SAPIEN 3 Ultra||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Transcatheter Aortic Valve Replacement (TAVR)
Device: SAPIEN 3 / SAPIEN 3 Ultra
Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra heart valve
No Intervention: CS
Clinical Surveillance (CS)
- A composite of death, stroke, and unplanned cardiovascular hospitalization [ Time Frame: 2 years ]The number of patients that had any of these events
- Death, unplanned cardiovascular hospitalization, decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ) score [ Time Frame: 2 years ]The number of patients that met all of 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
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
|Contact: Edwards THV Clinical Affairs||949-250-2500||THV_CT.gov@Edwards.com|
|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|