Actively Recruiting
PARTNER 3 Trial - Aortic Valve-in-Valve
Led by Edwards Lifesciences · Updated on 2024-05-10
125
Participants Needed
51
Research Sites
1108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
CONDITIONS
Official Title
PARTNER 3 Trial - Aortic Valve-in-Valve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Failing surgical or transcatheter bioprosthetic valve in the aortic position with moderate or worse stenosis and/or insufficiency
- Bioprosthetic valve true internal diameter between 18.5 mm and 28.5 mm
- New York Heart Association Functional Class II or higher
- Heart Team agrees patient is low to intermediate risk
- Heart Team agrees valve implantation will likely benefit the patient
- Patient informed about the study and provides written consent
You will not qualify if you...
- Surgical or transcatheter valve in the mitral position (mitral rings allowed)
- Severe regurgitation (greater than 3+) or stenosis of any other valve
- Moderate or severe paravalvular regurgitation of the failing valve
- Unstable, rocking, or structurally compromised failing valve
- Increased risk of coronary obstruction by prosthetic leaflets
- Increased risk of embolization of the transcatheter heart valve
- Residual mean gradient greater than 20 mmHg after original valve implantation
- Iliofemoral vessel anatomy not suitable for transfemoral access
- Anatomical issues preventing safe access to ascending aorta or apex
- Acute myocardial infarction within 30 days before enrollment
- Cardiac procedures with permanent implant within 30 days before procedure (except pacemaker or defibrillator)
- Planned concomitant ablation for atrial fibrillation
- Blood disorders or bleeding risk conditions
- Untreated significant coronary artery disease needing revascularization
- Hemodynamic or respiratory instability requiring support within 30 days
- Emergency interventional or surgical procedures within 30 days prior
- Planned surgical or coronary procedures within 30 days after valve procedure
- Hypertrophic cardiomyopathy with obstruction
- Left ventricular ejection fraction less than 30%
- Intracardiac mass, thrombus, or vegetation on imaging
- Unable to tolerate antithrombotic or anticoagulation therapy
- Allergy to iodinated contrast not manageable by premedication
- Stroke or transient ischemic attack within 90 days
- Symptomatic carotid or vertebral artery disease or recent carotid treatment
- Renal insufficiency or on renal replacement therapy at screening
- Active bacterial endocarditis within 180 days
- Refusal of blood products
- Life expectancy under 24 months
- Positive pregnancy test in women of childbearing potential
- Currently enrolled in another investigational drug or device study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Sutter Medical Center
Sacramento, California, United States, 95919
Actively Recruiting
4
Kaiser Permanente San Francisco
San Francisco, California, United States, 94115
Withdrawn
5
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
6
UC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
7
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
8
JFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, United States, 33462
Withdrawn
9
University of Florida, Gainesville
Gainesville, Florida, United States, 32610
Withdrawn
10
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
Northwestern University Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
12
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
13
Northshore University HealthSystem
Evanston, Illinois, United States, 60201
Withdrawn
14
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62701
Withdrawn
15
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
16
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
17
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
18
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Withdrawn
19
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Withdrawn
20
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
21
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States, 64111
Withdrawn
22
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
23
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
Withdrawn
24
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Withdrawn
25
Newark Beth Israel
Newark, New Jersey, United States, 07112
Actively Recruiting
26
University of Buffalo
Buffalo, New York, United States, 14203
Withdrawn
27
Winthrop University Hospital
Mineola, New York, United States, 11501
Actively Recruiting
28
New York University (NYU) Langone Medical Center
New York, New York, United States, 10016
Withdrawn
29
Cornell University
New York, New York, United States, 10021
Actively Recruiting
30
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
31
Carolina's Health System
Charlotte, North Carolina, United States, 28203
Withdrawn
32
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, United States, 27607
Withdrawn
33
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
34
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
35
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States, 73120
Withdrawn
36
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225
Actively Recruiting
37
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
38
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
39
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
40
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
Withdrawn
41
Saint Thomas Health Services
Nashville, Tennessee, United States, 37205
Withdrawn
42
Austin Heart, PLLC
Austin, Texas, United States, 78756
Withdrawn
43
Medical City Dallas Hospital
Dallas, Texas, United States, 75093
Actively Recruiting
44
The Heart Hospital Baylor Plano
Dallas, Texas, United States, 75093
Actively Recruiting
45
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
46
Intermountain Medical Center
Murray, Utah, United States, 84157
Actively Recruiting
47
University of Virginia
Charlottesville, Virginia, United States, 22908
Withdrawn
48
Inova Heart and vascular Instritute (Fairfax Inova)
Fairfax, Virginia, United States, 22042
Withdrawn
49
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Actively Recruiting
50
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Withdrawn
51
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
E
Edwards THV Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here