PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate

NCT ID: NCT03222128

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1074 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-17
• Study Completion Date: 2024-10-09

Brief Summary

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, and severe aortic stenosis, and those with intermediate risk.

Detailed Description

This study design consists of PIIS3i cohort.

The PIIS3i cohort is a single arm non-randomized, historical-controlled study. Patients recruited to the treatment arm will receive an Edwards SAPIEN 3 THV with either transfemoral, transapical or transaortic delivery access.

To ensure that patients are of "intermediate" risk, an STS score of 4 - 8% has been selected.

Conditions

Symptomatic Severe Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PIIS3i - SAPIEN 3

PIIS3i - SAPIEN 3 is Operable Group

Group Type: EXPERIMENTAL

TAVR

Intervention Type: DEVICE

Implantation of the SAPIEN 3

Interventions

TAVR

Implantation of the SAPIEN 3

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.

Exclusion Criteria

1. Heart team assessment of inoperability (including examining cardiac surgeon).

2. Complex coronary artery disease

1. Unprotected left main coronary artery

2. Syntax score > 32 (in the absence of prior revascularization)

3. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of screening evaluation.

4. Need for emergency surgery for any reason.

• Minimum Eligible Age: 19 Years
• 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

Scripps Green Hospital

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mercy General Hospital

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 Florida

Gainesville, 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

St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC

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

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

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Winthrop University Hospital

Mineola, New York, United States

Northshore Long Island Jewish Health System

New Hyde Park, New York, United States

Cornell University

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke University

Durham, North Carolina, 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

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

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

Countries

United States

References

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Other Identifiers

2010-12 PIIS3i

Identifier Type: -

Identifier Source: org_study_id