Clinical trial NCT01314313: PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
Official title: Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Severe Aortic Stenosis
Keywords: SAPIEN XT
Transfemoral
Transapical
Transaortic
NovaFlex
TAVI
Aortic Stenosis
THV
Aortic Valve
Transcatheter Heart Valve
TAVR
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 2032
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: All-cause Death or Disabling Stroke to Two Years
timeFrame: 2 Years
Secondary outcomes:
measure: Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
timeFrame: 2 years
measure: Total Aortic Regurgitation (AR) at 2 Years
timeFrame: 2 years
measure: 6MWT Change From Baseline
timeFrame: Baseline and 2 years
measure: NYHA Classification at 2 Years
timeFrame: 2 years
measure: Effective Orifice Area (EOA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital/Clinic
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: Northshore
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health-Methodist Hospital
state: Indiana
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Louisville
country: United States
facility: The Jewish Hospital Medical Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic-Saint Marys Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital - Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Greenville
country: United States
facility: East Carolina Heart Institute at East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Austin
country: United States
facility: Austin Heart, PLLC
state: Texas
city: Dallas
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio (UTHSCSA)
state: Texas
city: Murray
country: United States
facility: IHC Health Services Inc. dba Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Columbia University
name: Martin B Leon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Craig Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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