Clinical trial NCT00530894: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Official title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Aortic Stenosis
Keywords: Valvular Heart Disease
Critical/Severe Aortic Stenosis
High risk symptomatic patients
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 1057
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 study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.

Detailed description: Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.

Eligibility criteria: Inclusion Criteria Cohort A

1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2
3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
4. The subject or the subject'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 IRB of the respective clinical site
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

   Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and
6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.

Exclusion Criteria

1. Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.

Primary outcomes:
measure: Death
timeFrame: 1 Year
measure: Composite of Death and Recurrence Hospitalization.
timeFrame: duration of study
Secondary outcomes:
measure: Functional Change of NYHA
timeFrame: Baseline to 1 year
measure: Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
timeFrame: 1 year
measure: Total Hospital Days From the Index Procedure
timeFrame: 1 year
measure: Change in Quality of Life (QOL) From Baseline to 1 Year
timeFrame: Baseline and 1 Year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Memorial Hospital/Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: Boston Mass General
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic-Saint Marys Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish/Washington University
state: Missouri
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: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: Vancouver St. Paul's
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Quebec
country: Canada
facility: Laval Hospital
city: Leipzig
country: Germany
facility: Heart Center Leipzig
Study officials:
affiliation: New York-Presbyterian Hospital/Columbia University Medical Center
name: Martin B Leon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York-Presbyterian Hospital/Columbia University Medical Center
name: Craig Smith, MD
role: PRINCIPAL_INVESTIGATOR
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