PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

NCT ID: NCT01314313

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2032 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2024-01-17

Brief Summary

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.

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.

Conditions

Symptomatic Severe Aortic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PIIA - SAPIEN XT

PIIA is operable group

Group Type: EXPERIMENTAL

TAVR Implantation with SAPIEN XT

Intervention Type: DEVICE

Operable Group with SAPIEN XT

Control: SAVR

SAVR (surgical aortic valve replacement) is the control arm

Group Type: ACTIVE_COMPARATOR

SAVR Implantation

Intervention Type: DEVICE

Control Group

Interventions

TAVR Implantation with SAPIEN XT

Operable Group with SAPIEN XT

Intervention Type: DEVICE

SAVR Implantation

Control Group

Intervention Type: DEVICE

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin B Leon, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Craig Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Arkansas Heart Hospital/Clinic

Little Rock, Arkansas, United States

Scripps Green Hospital

La Jolla, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mercy General Hospital

Sacramento, California, United States

UC Davis Medical Center

Sacramento, California, United States

Stanford University Medical Center

Stanford, California, United States

University of Colorado Hospital

Denver, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

University of Miami Hospital Miller School of Medicine

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Northshore

Evanston, Illinois, United States

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Indiana University Health-Methodist Hospital

Indianapolis, Indiana, United States

The University of Iowa

Iowa City, Iowa, United States

The Jewish Hospital Medical Center

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Maryland, Baltimore

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Mayo Clinic-Saint Marys Hospital

Rochester, Minnesota, United States

St. Luke's Hospital - Mid America Heart Institute

Kansas City, Missouri, United States

Washington University - Barnes Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Cooper University

Camden, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Winthrop University Hospital

Mineola, New York, United States

New York Presbyterian Hospital - Cornell

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

East Carolina Heart Institute at East Carolina University

Greenville, North Carolina, United States

The Lindner Center for Research & Education at The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, United States

Providence Heart & Vascular Institute at Providence St. Vincent Medical Center

Portland, Oregon, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Austin Heart, PLLC

Austin, Texas, United States

The Heart Hospital Baylor Plano

Dallas, Texas, United States

Medical City Dallas

Dallas, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Texas Health Science Center at San Antonio (UTHSCSA)

San Antonio, Texas, United States

IHC Health Services Inc. dba Intermountain Medical Center

Murray, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

University of Washington

Seattle, Washington, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, , Canada

Countries

United States; Canada

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Other Identifiers

2010-12 PIIA

Identifier Type: -

Identifier Source: org_study_id