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

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Aortic Stenosis, Calcific

• Registration Number: NCT04889872
• Lead Sponsor: Edwards Lifesciences

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 Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-12
• Study First Posted: 2021-05-17
• Study Start: 2021-10-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2029-06
• Study Completion: 2037-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	2 years	Non-hierarchical composite of death, and heart failure hospitalization or event
Primary Safety Endpoint	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

Name	Time	Method
Unplanned cardiovascular hospitalization	2 years	The number of patients that had this event
KCCQ overall score	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.
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)	2 years	The number of patients that met all these criteria
Death, stroke, or unplanned cardiovascular hospitalization	2 years	The number of patients that had this event
Left ventricle (LV) mass index	2 years	Echocardiographic measurement of the size of the left ventricle
Diastolic dysfunction ≥ Grade 2	2 years	Echocardiographic measurement of the stiffness of the left ventricle.
Reduction in LVEF ≥ 5% from baseline AND LVEF < 60%	2 years	The number of patients that meet these criteria
Stroke volume index	2 years	Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)	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.
New onset atrial fibrillation	2 years	The number of patients that develop this condition

Trial Locations

Locations (80)

Heart Center LLC, Huntsville; 🇺🇸 Huntsville, Alabama, United States

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Huntington Hospital; 🇺🇸 Pasadena, California, United States

Eisenhower Desert Cardiology Center; 🇺🇸 Rancho Mirage, California, United States

Bay Area Structural Heart at Sutter Health; 🇺🇸 San Francisco, California, United States

Kaiser San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Santa Barbara Cottage Hospital; 🇺🇸 Santa Barbara, California, United States

Stanford Univeristy; 🇺🇸 Stanford, California, United States

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