Trial Search Results

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

The purpose of this study is to determine the safety and effectiveness of the SAPIEN XTâ„¢ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Edwards Lifesciences

Collaborator: American College of Cardiology

Intervention(s):

  • Device: TAVR Implantation with SAPIEN XT
  • Device: TAVR Implantation with SAPIEN

Phase:

N/A

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   withdrawn from the PARTNER I Trial prior to endpoint analysis.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.

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting