The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)

August 27, 2018 updated by: Edwards Lifesciences

The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable).

Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

Study Type

Interventional

Enrollment (Actual)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital/Clinic
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95816
        • Mercy General Hospital
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center (WHC)
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Gainesville, Florida, United States, 32610
        • University of Florida, Gainesville
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Hospital
      • Springfield, Illinois, United States, 62701
        • Prairie Education And Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health-Methodist Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - Jewish Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City Mid America
      • Saint Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital, NY
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • Cornell University
    • North Carolina
      • Charleston, North Carolina, United States, 29425
        • Medical University of South Carolina Charleston
      • Greenville, North Carolina, United States, 27834
        • East Carolina Heart Institute at East Carolina University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital, Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart, PLLC
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio (UTHSCSA)
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22904
        • University of Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAVR - SAPIEN XT
TAVR (transaortic valve replacement) with SAPIEN XT
Device: TAVR Implantation with SAPIEN XT
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Active Comparator: TAVR - SAPIEN
TAVR (transaortic valve replacement) with SAPIEN is the control arm
Device: TAVR Implantation with SAPIEN
Inoperable operable patients requiring the transcatheter aortic heart valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Time Frame: 1 Year
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NYHA Classification - Change From Baseline
Time Frame: Baseline and 1 Year
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
Total Aortic Regurgitation - Change From Baseline
Time Frame: 1 Year

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
Effective Orifice Area - Change From Baseline
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Collaborators

American College of Cardiology

Investigators

  • Principal Investigator: Martin B Leon, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

January 17, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-12-PIIB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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