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

Aortic Valve Stenosis Clinical Trial

— PROGRESS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889872
• Other study ID #: 2021-01
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: June 2037

Study information

• Verified date: April 2024
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: 949-250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: June 2037
• Est. primary completion date: June 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis, Calcific
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Health	Clayton	Victoria
Canada	Hamiton Health Services	Hamilton	Onterio
Canada	St. Paul's Hospital	Vancouver	British Columbia
Japan	Sakakibara Heart Institute	Fuchu	Tokyo
Japan	Kokura Memorial Hospital	Fukuoka	Kyushu
Japan	Sendai Kousei Hospital	Sendai	Miyagi
Japan	Keio University Hospital	Shinjuku	Tokyo
Netherlands	AMC Amsterdam	Amsterdam	North Holland
Netherlands	Leiden Universitair Medisch Centrum	Leiden	South Holland
Netherlands	Erasmus Rotterdam	Rotterdam	South Holland
Switzerland	Hôpitaux Universitaire de Genève	Geneva
Switzerland	Universitätsspital Zürich	Zürich
United States	Emory University Atlanta	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Ascension Texas Cardiovascular	Austin	Texas
United States	Saint Alphonsus	Boise	Idaho
United States	Massachusetts General Hospital Boston	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Buffalo Kaleida Health	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Kaiser Permanente Northwest	Clackamas	Oregon
United States	Mount Carmel Health System	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	The Cardiac & Vascular Institute Research Foundation	Gainesville	Florida
United States	Baptist Memorial Hospital Memphis	Germantown	Tennessee
United States	Methodist Le Bonheur Healthcare	Germantown	Tennessee
United States	Moses Cone Memorial Hospital	Greensboro	North Carolina
United States	HCA Houston Healthcare Medical Center	Houston	Texas
United States	The University of Texas Health Science Center	Houston	Texas
United States	Heart Center LLC, Huntsville	Huntsville	Alabama
United States	Baptist Health Research Center	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City Mid America	Kansas City	Missouri
United States	Parkwest Medical Center	Knoxville	Tennessee
United States	Mary Hitchcock Memorial Hospital	Lebanon	New Hampshire
United States	Alexian Brothers Hospital	Lisle	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	UC Health Medical Center of the Rockies	Loveland	Colorado
United States	Kaiser Mid Atlantic	McLean	Virginia
United States	NYU Langone Hospital - Long Island	Mineola	New York
United States	Minneapolis Heart Institue, St. Paul's	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Atlantic Health System Hospital Corp - Morristown Medical Center	Morristown	New Jersey
United States	Saint Thomas Health	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale Universtiy	New Haven	Connecticut
United States	Louisiana State University	New Orleans	Louisiana
United States	Ochsner Clinical Foundation	New Orleans	Louisiana
United States	Columbia University Irving Medical Center/NYPH	New York	New York
United States	NYU Langone Health	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Huntington Hospital	Pasadena	California
United States	Allegheny Singer Research Institute	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Legacy Emanuel Medical Center	Portland	Oregon
United States	Providence Heart & Vascular Institute Portland	Portland	Oregon
United States	Eisenhower Desert Cardiology Center	Rancho Mirage	California
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Rochester General Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota
United States	Methodist Hospital of San Antonio	San Antonio	Texas
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	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford Univeristy	Stanford	California
United States	Tucson Medical Center	Tucson	Arizona
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Cardiovascular Research Institute of Kansas	Wichita	Kansas
United States	Pinnacle Health Harrisburg	Wormleysburg	Pennsylvania
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	Non-hierarchical composite of death, and heart failure hospitalization or event	2 years
Primary	Primary Safety Endpoint	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	30 days
Secondary	Death, stroke, or unplanned cardiovascular hospitalization	The number of patients that had this event	2 years
Secondary	Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)	The number of patients that met all these criteria	2 years
Secondary	Unplanned cardiovascular hospitalization	The number of patients that had this event	2 years
Secondary	Left ventricle (LV) mass index	Echocardiographic measurement of the size of the left ventricle	2 years
Secondary	Stroke volume index	Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.	2 years
Secondary	Diastolic dysfunction = Grade 2	Echocardiographic measurement of the stiffness of the left ventricle.	2 years
Secondary	N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)	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.	2 years
Secondary	KCCQ overall score	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.	2 years
Secondary	Reduction in LVEF = 5% from baseline AND LVEF < 60%	The number of patients that meet these criteria	2 years
Secondary	New onset atrial fibrillation	The number of patients that develop this condition	2 years