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

Primary Purpose

Aortic Stenosis, Calcific, Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis, Calcific focused on measuring Transcatheter aortic valve replacement (TAVR), SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA, Moderate aortic stenosis, Aortic stenosis, Transcatheter heart valve

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Heart Center LLC, HuntsvilleRecruiting
  • Tucson Medical CenterRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Huntington Hospital
  • Eisenhower Desert Cardiology CenterRecruiting
  • Bay Area Structural Heart at Sutter HealthRecruiting
  • Kaiser San Francisco Medical CenterRecruiting
  • Santa Barbara Cottage HospitalRecruiting
  • Stanford UniveristyRecruiting
  • UC Health Medical Center of the RockiesRecruiting
  • Yale UniverstiyRecruiting
  • The Cardiac & Vascular Institute Research Foundation
  • Baptist Health Research CenterRecruiting
  • Sarasota Memorial Health Care SystemRecruiting
  • Emory University AtlantaRecruiting
  • Piedmont Heart InstituteRecruiting
  • Saint AlphonsusRecruiting
  • Rush University Medical CenterRecruiting
  • Alexian Brothers HospitalRecruiting
  • Cardiovascular Research Institute of KansasRecruiting
  • Ochsner Clinical FoundationRecruiting
  • Massachusetts General Hospital BostonRecruiting
  • Minneapolis Heart Institue, St. Paul'sRecruiting
  • CentraCare Heart and Vascular CenterRecruiting
  • Saint Luke's Hospital of Kansas City Mid AmericaRecruiting
  • St. Patrick HospitalRecruiting
  • Mary Hitchcock Memorial HospitalRecruiting
  • Atlantic Health System Hospital Corp - Morristown Medical CenterRecruiting
  • Jersey Shore University Medical CenterRecruiting
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • The Valley HospitalRecruiting
  • Montefiore Medical CenterRecruiting
  • University of Buffalo Kaleida HealthRecruiting
  • NYU Langone Hospital - Long IslandRecruiting
  • NYU Langone Health
  • Columbia University Irving Medical Center/NYPHRecruiting
  • Rochester General HospitalRecruiting
  • St. Francis HospitalRecruiting
  • Moses Cone Memorial HospitalRecruiting
  • The Christ HospitalRecruiting
  • Mount Carmel Health SystemRecruiting
  • Oklahoma Heart InstituteRecruiting
  • Kaiser Permanente Northwest
  • Providence Heart & Vascular Institute Portland
  • Legacy Emanuel Medical CenterRecruiting
  • Allegheny Singer Research InstituteRecruiting
  • UPMC Presbyterian ShadysideRecruiting
  • Pinnacle Health HarrisburgRecruiting
  • Lankenau Medical CenterRecruiting
  • Baptist Memorial Hospital MemphisRecruiting
  • Methodist Le Bonheur HealthcareRecruiting
  • Parkwest Medical CenterRecruiting
  • Saint Thomas HealthRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Ascension Texas CardiovascularRecruiting
  • UT Southwestern Medical CenterRecruiting
  • HCA Houston Healthcare Medical CenterRecruiting
  • The University of Texas Health Science CenterRecruiting
  • The Heart Hospital Baylor PlanoRecruiting
  • Methodist Hospital of San AntonioRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Swedish Medical CenterRecruiting
  • The Prince Charles HospitalRecruiting
  • Royal Adelaide HospitalRecruiting
  • Flinders Medical CentreRecruiting
  • Monash HealthRecruiting
  • St. Paul's HospitalRecruiting
  • Hamiton Health ServicesRecruiting
  • Kokura Memorial HospitalRecruiting
  • Sendai Kousei HospitalRecruiting
  • Sakakibara Heart InstituteRecruiting
  • Keio University HospitalRecruiting
  • AMC AmsterdamRecruiting
  • Leiden Universitair Medisch CentrumRecruiting
  • Erasmus RotterdamRecruiting
  • Hôpitaux Universitaire de GenèveRecruiting
  • Universitätsspital ZürichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAVR

CS

Arm Description

Transcatheter Aortic Valve Replacement (TAVR)

Clinical Surveillance (CS)

Outcomes

Primary Outcome Measures

Primary Effectiveness Endpoint
Non-hierarchical composite of death, and heart failure hospitalization or event
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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2021
Last Updated
October 5, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04889872
Brief Title
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
June 2037 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Calcific, Aortic Valve Stenosis
Keywords
Transcatheter aortic valve replacement (TAVR), SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA, Moderate aortic stenosis, Aortic stenosis, Transcatheter heart valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVR
Arm Type
Experimental
Arm Description
Transcatheter Aortic Valve Replacement (TAVR)
Arm Title
CS
Arm Type
No Intervention
Arm Description
Clinical Surveillance (CS)
Intervention Type
Device
Intervention Name(s)
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Intervention Description
Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Non-hierarchical composite of death, and heart failure hospitalization or event
Time Frame
2 years
Title
Primary Safety Endpoint
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Death, stroke, or unplanned cardiovascular hospitalization
Description
The number of patients that had this event
Time Frame
2 years
Title
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
The number of patients that met all these criteria
Time Frame
2 years
Title
Unplanned cardiovascular hospitalization
Description
The number of patients that had this event
Time Frame
2 years
Title
Left ventricle (LV) mass index
Description
Echocardiographic measurement of the size of the left ventricle
Time Frame
2 years
Title
Stroke volume index
Description
Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
Time Frame
2 years
Title
Diastolic dysfunction ≥ Grade 2
Description
Echocardiographic measurement of the stiffness of the left ventricle.
Time Frame
2 years
Title
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP)
Description
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.
Time Frame
2 years
Title
KCCQ overall score
Description
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.
Time Frame
2 years
Title
Reduction in LVEF ≥ 5% from baseline AND LVEF < 60%
Description
The number of patients that meet these criteria
Time Frame
2 years
Title
New onset atrial fibrillation
Description
The number of patients that develop this condition
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 65 years of age or older at time of randomization Moderate aortic stenosis Subject has symptoms or evidence of cardiac damage/dysfunction 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: Native aortic annulus size unsuitable for the THV Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system Aortic valve is unicuspid or non-calcified Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification Pre-existing mechanical or bioprosthetic aortic valve Severe aortic regurgitation Prior balloon aortic valvuloplasty to treat severe AS LVEF < 20% Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwards THV Clinical Affairs
Phone
949-250-2500
Email
THV_CT.gov@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Généreux, MD
Organizational Affiliation
Morristown Medical Center, Morristown, NJ, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeroen J Bax, MD, PhD
Organizational Affiliation
Leiden University Medical Center, Leiden, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
Organizational Affiliation
Cedars-Sinai Medical Center, Los Angeles, CA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center LLC, Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Name
Tucson Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntington Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Withdrawn
Facility Name
Eisenhower Desert Cardiology Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Area Structural Heart at Sutter Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Univeristy
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Health Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Universtiy
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cardiac & Vascular Institute Research Foundation
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Withdrawn
Facility Name
Baptist Health Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarasota Memorial Health Care System
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Alphonsus
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Alexian Brothers Hospital
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Clinical Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Minneapolis Heart Institue, St. Paul's
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Name
CentraCare Heart and Vascular Center
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Luke's Hospital of Kansas City Mid America
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Patrick Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Individual Site Status
Recruiting
Facility Name
Mary Hitchcock Memorial Hospital
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlantic Health System Hospital Corp - Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Buffalo Kaleida Health
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Hospital - Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University Irving Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Name
Moses Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Recruiting
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Carmel Health System
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Northwest
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Providence Heart & Vascular Institute Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Withdrawn
Facility Name
Legacy Emanuel Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Presbyterian Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Pinnacle Health Harrisburg
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Individual Site Status
Recruiting
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Memorial Hospital Memphis
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist Le Bonheur Healthcare
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Parkwest Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Texas Cardiovascular
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
HCA Houston Healthcare Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Methodist Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Individual Site Status
Recruiting
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E1M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hamiton Health Services
City
Hamilton
State/Province
Onterio
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Kokura Memorial Hospital
City
Fukuoka
State/Province
Kyushu
ZIP/Postal Code
802-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sakakibara Heart Institute
City
Fuchu
State/Province
Tokyo
ZIP/Postal Code
183-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
AMC Amsterdam
City
Amsterdam
State/Province
North Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leiden Universitair Medisch Centrum
City
Leiden
State/Province
South Holland
ZIP/Postal Code
2333
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Rotterdam
City
Rotterdam
State/Province
South Holland
ZIP/Postal Code
3015
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hôpitaux Universitaire de Genève
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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