Calcific Aortic Stenosis Clinical Trial
— PARTNERII BOfficial title:
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
NCT number | NCT02184442 |
Other study ID # | 2010-12-PIIB |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 9, 2011 |
Est. completion date | May 30, 2017 |
Verified date | August 2018 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Status | Completed |
Enrollment | 560 |
Est. completion date | May 30, 2017 |
Est. primary completion date | May 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria 1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. 2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%. 3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient. 4. 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. 5. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up. Exclusion Criteria 1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral) 3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis. 5. Active bacterial endocarditis within 6 months (180 days) of procedure. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
United States | Austin Heart, PLLC | Austin | Texas |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Medical University of South Carolina Charleston | Charleston | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern Hospital | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | The Christ Hospital, Cincinnati | Cincinnati | Ohio |
United States | Morton Plant Hospital | Clearwater | Florida |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | The Heart Hospital Baylor Plano | Dallas | Texas |
United States | University of Colorado Hospital | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | University of Florida, Gainesville | Gainesville | Florida |
United States | East Carolina Heart Institute at East Carolina University | Greenville | North Carolina |
United States | The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center | Houston | Texas |
United States | Indiana University Health-Methodist Hospital | Indianapolis | Indiana |
United States | The University of Iowa | Iowa City | Iowa |
United States | Saint Luke's Hospital of Kansas City Mid America | Kansas City | Missouri |
United States | Scripps Green Hospital | La Jolla | California |
United States | Scripps Memorial Hospital | La Jolla | California |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Nebraska Heart Institute | Lincoln | Nebraska |
United States | Arkansas Heart Hospital/Clinic | Little Rock | Arkansas |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | University of Louisville - Jewish Hospital | Louisville | Kentucky |
United States | University of Wisconsin - Madison | Madison | Wisconsin |
United States | North Shore University Hospital, NY | Manhasset | New York |
United States | Baptist Memorial Hospital | Memphis | Tennessee |
United States | University of Miami | Miami | Florida |
United States | Winthrop University Hospital | Mineola | New York |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | Intermountain Medical Center | Murray | Utah |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Columbia University Medical Center | New York | New York |
United States | Cornell University | New York | New York |
United States | Newark Beth Israel | Newark | New Jersey |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
United States | University of Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Mercy General Hospital | Sacramento | California |
United States | Washington University - Barnes Jewish Hospital | Saint Louis | Missouri |
United States | University of Texas Health Science Center at San Antonio (UTHSCSA) | San Antonio | Texas |
United States | University of Washington | Seattle | Washington |
United States | Prairie Education and Research Cooperative | Springfield | Illinois |
United States | Stanford University Medical Center | Stanford | California |
United States | Washington Hospital Center (WHC) | Washington | District of Columbia |
United States | York Hospital | York | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences | American College of Cardiology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization | All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year | 1 Year | |
Secondary | NYHA Classification - Change From Baseline | New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort. | Baseline and 1 Year | |
Secondary | Total Aortic Regurgitation - Change From Baseline | Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe. Total regurgitation at one year was analyzed in the valve implant population. |
1 Year | |
Secondary | Effective Orifice Area - Change From Baseline | 1 Year |
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