THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

Not Applicable

Completed

• Conditions: Critical Aortic Stenosis

• Registration Number: NCT00530894
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-18
• Primary Completion: 2010-09
• Results First Submitted: 2016-03-07
• Results First Submitted QC: 2017-04-03
• Results First Posted: 2017-05-11
• Study Completion: 2017-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1057

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Death	1 Year	Death from any cause.
Composite of Death and Recurrence Hospitalization.	duration of study	Death from any cause or repeat hospitalization after intervention.

Secondary Outcome Measures

Name	Time	Method
Functional Change of NYHA	Baseline to 1 year	NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)	1 year	Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Total Hospital Days From the Index Procedure	1 year	Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Change in Quality of Life (QOL) From Baseline to 1 Year	Baseline and 1 Year	The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states.; KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status.; SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.

Trial Locations

Locations (26)

Scripps Memorial Hospital/Scripps Green Hospital; 🇺🇸 La Jolla, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Washington Hospital Center; 🇺🇸 Washington, D.C., District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

Ochsner Clinic; 🇺🇸 New Orleans, Louisiana, United States

Boston Mass General; 🇺🇸 Boston, Massachusetts, United States

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