PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
PII NR3/ViV
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
1 other identifier
interventional
197
2 countries
47
Brief Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2016
CompletedFirst Submitted
Initial submission to the registry
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedResults Posted
Study results publicly available
January 9, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedMarch 9, 2021
February 1, 2021
4.5 years
July 17, 2017
December 7, 2017
February 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
30-day
Secondary Outcomes (1)
Number of Participants With Mortality From Any Cause
30 Days
Study Arms (1)
Failing surgical valve
EXPERIMENTALPatients with a failing surgical bioprosthetic valve in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Interventions
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
Eligibility Criteria
You may qualify if:
- Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA \< 0.5 cm2/m2. Qualifying echo must be within 60 days of the date of the procedure.
- Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
- The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- Heart team consensus that the risk of surgical mortality or major morbidity ≥ 50%.
- Stenosed or insufficient surgically implanted bioprosthetic valve in the aortic position.
You may not qualify if:
- Bioprosthetic valve labeled external diameter \< 21mm.
- Infectious endocarditis within 6 months.
- Acute myocardial infarction ≤ 1 month (30 days) before the intended treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Scripps Green Hospital
La Jolla, California, 92037, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mercy General Hospital
Sacramento, California, 95819, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado Hospital
Denver, Colorado, 80045, United States
Washington Hospital Center (WHC)
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
University of Miami
Miami, Florida, 33136, United States
Emory University Hospital
Atlanta, Georgia, 30341, United States
Northwestern Hospital
Chicago, Illinois, 60611, United States
NorthShore University HealthSystem Research Institute
Evanston, Illinois, 60201, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
University of Louisville Jewish Hospital
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48130, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Mayo Clinic-Saint Marys Hospital
Rochester, Minnesota, 55905, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Winthrop-University Hospital
Mineola, New York, 11501, United States
Cornell University
New York, New York, 10021, United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032, United States
East Carolina Heart Institute at East Carolina University
Greenville, North Carolina, 27834, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135, United States
Providence St.Vincent Medical Center
Portland, Oregon, 97225, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Heart Hospital Baylor Plano
Dallas, Texas, 75093, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Intermountain Medical Center
Salt Lake City, Utah, 84157, United States
University of Virginia
Charlottesville, Virginia, 22904, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
University of Washington
Seattle, Washington, 98101, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792, United States
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, V6Z 1Y6, Canada
Related Publications (2)
Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
PMID: 35656983DERIVEDWebb JG, Murdoch DJ, Alu MC, Cheung A, Crowley A, Dvir D, Herrmann HC, Kodali SK, Leipsic J, Miller DC, Pibarot P, Suri RM, Wood D, Leon MB, Mack MJ. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019 Jun 4;73(21):2647-2655. doi: 10.1016/j.jacc.2019.03.483.
PMID: 31146808DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Edwards THV Clinical Affairs
- Organization
- Edwards Lifesciences
Study Officials
- PRINCIPAL INVESTIGATOR
John Webb, MD
St. Paul's Hospital, Vancouver, British columbia, Canada
- PRINCIPAL INVESTIGATOR
Michael Mack, MD
Baylor Heart Hospital, Plano, TX
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 21, 2017
Study Start
June 11, 2012
Primary Completion
December 16, 2016
Study Completion
October 28, 2020
Last Updated
March 9, 2021
Results First Posted
January 9, 2018
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share