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

Symptomatic Severe Aortic Stenosis Clinical Trial

— PII A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314313
• Other study ID #: 2010-12 PIIA
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: January 17, 2024

Study information

• Verified date: March 2024
• 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 XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2032
• Est. completion date: January 17, 2024
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A 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.

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).

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Severe Aortic Stenosis

Intervention

Device:
• TAVR Implantation with SAPIEN XT
Operable Group with SAPIEN XT
• SAVR Implantation
Control Group

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia
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	Massachusetts General Hospital	Boston	Massachusetts
United States	Cooper University	Camden	New Jersey
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	Northshore	Evanston	Illinois
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	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	Scripps Memorial Hospital	La Jolla	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Arkansas Heart Hospital/Clinic	Little Rock	Arkansas
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	Baptist Memorial Hospital	Memphis	Tennessee
United States	University of Miami Hospital Miller School of Medicine	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	IHC Health Services Inc. dba Intermountain Medical Center	Murray	Utah
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital - Cornell	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	UC Davis Medical Center	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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death or Disabling Stroke to Two Years	All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)	2 Years
Secondary	Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	The number of days the patients are alive and out of the hospital.	2 years
Secondary	Total Aortic Regurgitation (AR) at 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
Secondary	6MWT Change From Baseline	Six Minute Walk Test change from baseline to 2 years	Baseline and 2 years
Secondary	NYHA Classification at 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
Secondary	Effective Orifice Area (EOA)		2 years