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Sponsored by: |
Edwards Lifesciences |
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Information provided by: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT00530894 |
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.
Condition | Intervention |
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Critical Aortic Stenosis |
Device: Edwards SAPIEN Transcatheter Heart Valve Device: Surgical Valve Replacement Other: medical management and/or balloon aortic valvuloplasty |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve |
Estimated Enrollment: | 1040 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | September 2014 |
Arms | Assigned Interventions |
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1: Experimental
Cohort A: Sapien Valve
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Device: Edwards SAPIEN Transcatheter Heart Valve |
2: Active Comparator
Cohort A: other surgical valve
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Device: Surgical Valve Replacement |
3: Experimental
Cohort B: Sapien Valve
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Device: Edwards SAPIEN Transcatheter Heart Valve |
4: Active Comparator
Cohort B: Medical therapy
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Other: medical management and/or balloon aortic valvuloplasty |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria Cohort A
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
Exclusion Criteria
Contact: Jodi Akin | 949.250.2730 | jodi_akin@edwards.com |
Principal Investigator: | Martin B Leon, MD | New York-Presbyterian Hospital/Columbia Univerity Medical Center |
Principal Investigator: | Craig Smith, MD | New York-Presbyterian Hospital/Columbia Univerity Medical Center |
Study ID Numbers: | 2006-06-US |
Study First Received: | September 14, 2007 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00530894 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada |
Valvular Heart Disease Critical/Severe Aortic Stenosis High risk symptomatic patients |
Heart Diseases Constriction, Pathologic Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |