PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 (PII S3HR/NR7)

April 23, 2021 updated by: Edwards Lifesciences

Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for High Risk and Inoperable Patients

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis, and are in high risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-randomized, multi-center trial for patients undergoing aortic valve replacement with the Edwards SAPIEN 3 THV for severe aortic stenosis. Patient cohorts will include those inoperable and those considered as a high surgical risk (STS ≥8%). The study also includes NR7 patients (patients with a 20mm vessel size).

Study Type

Interventional

Enrollment (Actual)

583

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
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital, Providence Health Care
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95819
        • 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 DC
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • 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
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • MedStar Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • 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
      • Saint Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Jersey
      • 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
        • Cornell University
    • North Carolina
      • Durham, North Carolina, United States, 27712
        • Duke University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Oklahoma Heart Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St.Vincent Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • York, Pennsylvania, United States, 17403
        • York Hospital
    • Texas
      • Austin, Texas, United States, 78756
        • Austin Heart, PLLC
      • Dallas, Texas, United States, 75230
        • Medical City Dallas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • 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

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 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. STS > 8

Exclusion Criteria:

  1. Pre-existing mechanical or bioprosthetic valve in any position.
  2. Active bacterial endocarditis within 6 months (180 days) of procedure.
  3. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  4. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure. Implantation of a permanent pacemaker or ICD is not considered exclusion criteria.
  5. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAPIEN 3™ valve
Device: TAVR Implantation of the THV Prosthesis
Patients with TAVR implantation
Other Names:
  • SAPIEN 3™valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
Time Frame: 30 Days
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Major Vascular Complications
Time Frame: 30 Days
The rate of major vascular complications at 30 days post implantation
30 Days
Number of Participants With Aortic Insufficiency at 30 Days
Time Frame: 30 Days
The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
30 Days

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

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)

October 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-12 S3HR/NR7

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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