PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A)

March 5, 2024 updated by: Edwards Lifesciences

Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery.

To assure that patients with an STS score ≥ 4% have been selected.

Study Type

Interventional

Enrollment (Actual)

2032

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

  • Canada
      • Quebec, Canada, G1V465
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, Providence Health Care
  • 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, 95817
        • UC Davis 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
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Hospital Miller School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Evanston, Illinois, United States, 60201
        • Northshore
      • 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
        • The Jewish Hospital Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore
    • 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-Saint Marys Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital - Mid America Heart Institute
      • 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
      • Camden, New Jersey, United States, 08103
        • Cooper University
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • 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
        • New York Presbyterian Hospital - Cornell
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • East Carolina Heart Institute at East Carolina University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research & Education at The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Hospital
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart, PLLC
      • Dallas, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • Dallas, Texas, United States, 75230
        • Medical City Dallas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Science Center at San Antonio (UTHSCSA)
    • Utah
      • Murray, Utah, United States, 84157
        • IHC Health Services Inc. dba 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. 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.
  2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
  6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

Exclusion Criteria

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
  6. Heart team assessment of inoperability (including examining cardiac surgeon).

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: PIIA - SAPIEN XT
PIIA is operable group
Device: TAVR Implantation with SAPIEN XT
Operable Group with SAPIEN XT
Active Comparator: Control: SAVR
SAVR (surgical aortic valve replacement) is the control arm
Device: SAVR Implantation
Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Death or Disabling Stroke to Two Years
Time Frame: 2 Years
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
2 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
Time Frame: 2 years
The number of days the patients are alive and out of the hospital.
2 years
Total Aortic Regurgitation (AR) at 2 Years
Time Frame: 2 years
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 two year was analyzed in the valve implant population.
2 years
6MWT Change From Baseline
Time Frame: Baseline and 2 years
Six Minute Walk Test change from baseline to 2 years
Baseline and 2 years
NYHA Classification at 2 Years
Time Frame: 2 years
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.
2 years
Effective Orifice Area (EOA)
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Martin B Leon, MD, Columbia University
  • Principal Investigator: Craig Smith, 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 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (Estimated)

March 14, 2011

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-12 PIIA

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.

Clinical Trials on Symptomatic Severe Aortic Stenosis

Clinical Trials on TAVR Implantation with SAPIEN XT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe