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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
Not Recruiting
Trial ID: NCT02184442
Purpose
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV
with the associated delivery system for inoperable patients with severe symptomatic native
aortic stenosis.
Official Title
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
Stanford Investigator(s)
Rajesh Dash, MD PhD; Director of SSATHI & CardioClick
Associate Professor of Medicine (Cardiovascular Medicine)
Eligibility
Inclusion Criteria
1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA
Functional Class II or greater.
2. The probability of death or serious, irreversible morbidity is greater than or equal
to 50%.
3. The heart team agreed (and verified in the case review process) that valve
implantation would likely benefit the patient.
4. The study patient or the study patient's legal representative was informed of the
nature of the study, agreed to its provisions and had provided written informed
consent as approved by the Institutional Review Board (IRB) of the respective clinical
site.
5. The study patient agreed to comply with all required post-procedure follow-up visits
including annual visits through 5 years and analysis close date visits, which was
conducted as a phone follow-up.
Exclusion Criteria
1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
non-calcified.
2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch
atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing
(especially with calcification and surface irregularities) of the abdominal or
thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
(Transfemoral)
3. Currently participating in an investigational drug or another device study. Note:
Trials requiring extended follow-up for products that were investigational, but have
since become commercially available, are not considered investigational trials.
4. It is known that the patient is currently enrolled in the PARTNER I Trial or was
withdrawn from the PARTNER I Trial prior to endpoint analysis.
5. Active bacterial endocarditis within 6 months (180 days) of procedure.
Intervention(s):
device: TAVR Implantation with SAPIEN XT
device: TAVR Implantation with SAPIEN
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305