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

Symptomatic Severe Aortic Stenosis Clinical Trial

— PII S3i  

Official title:

Edwards SAPIEN 3 Transcatheter Heart Valve Therapy for Intermediate Risk Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03222128
• Other study ID #: 2010-12 PIIS3i
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2014
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1074
• Est. completion date: November 2025
• Est. primary completion date: November 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

Intervention

Device:
• TAVR
Implantation of the SAPIEN 3

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Austin Heart, PLLC	Austin	Texas
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Medical City Dallas	Dallas	Texas
United States	The Heart Hospital Baylor Plano	Dallas	Texas
United States	University of Colorado Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	Northshore	Evanston	Illinois
United States	University of Florida	Gainesville	Florida
United States	East Carolina Heart Institute at East Carolina University	Greenville	North Carolina
United States	The University of Texas Health Science Center at Houston	Houston	Texas
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	St. Luke's Hospital - Mid America Heart Institute	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	The Jewish Hospital Medical Center	Louisville	Kentucky
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Northshore Long Island Jewish Health System	New Hyde Park	New York
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Cornell University	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Providence Heart & Vascular Institute at Providence St. Vincent Medical Center	Portland	Oregon
United States	Mayo Clinic-Saint Marys Hospital	Rochester	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Washington University - Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio (UTHSCSA)	San Antonio	Texas
United States	University of Washington	Seattle	Washington
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Washington Hospital Center	Washington	District of Columbia
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) = Moderate		1 year
Secondary	Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days		30 Days