Severe Symptomatic Aortic Stenosis Clinical Trial
Official title:
Transcatheter Valve Therapy (TVT) Registry Assessment of Alternative Access Approaches for Transcatheter Aortic Valve Replacement (TAVR) in Inoperable Patients With Severe Aortic Stenosis
Investigational study of Edwards Lifesciences, LLC's "Edwards SAPIEN Transcatheter Heart Valve" for non-femoral delivery, (or alternative access deliver) in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis. Will outcomes observed in a high-risk operable transapical native valve TAVR cohort receiving an Edwards SAPIEN device compare to inoperable patients undergoing alternative access TAVR with the Edwards SAPIEN device experience a reasonably similar incidence of 30 day adverse events?
Transcatheter aortic valve replacement (TAVR) using the Edwards SAPIEN valve and Retroflex 3
delivery system provides both a mortality and quality of life benefit for inoperable
patients. Only the transfemoral (TF) access has been approved in the US. A substantial
number of patients cannot have a TF approach due to inadequate vessel size, vessel disease,
or other anatomical considerations. The pivotal study did not include an assessment of
safety and effectiveness of alternative access approaches in this inoperable patient group.
Early approaches to TAVR included a femoral transvenous approach with transseptal access to
the left side for delivery of the valve. This approach avoided large bore arterial
catheterization, but it had unacceptable rates of complications and lacked reproducibility.
Alternative access approaches have been developed because of the risks associated with
inserting large caliber catheters into small, diseased femoral arteries often associated
with diffuse vasculopathy. To avoid the vascular complications from femoral access, other
transcatheter approaches have been developed to include open surgical access to the left
ventricular apex (TA), ascending aorta, (TAO), subclavian and axillary arteries (TS), and
retroperitoneal access to the iliac artery (TI) as well as distal aorta. In addition to
providing TAVR to patients who cannot have TF access, additional advantages include better
catheter control and safer closure of the access site. Commonly cited disadvantages include
the need for surgical expertise and additional equipment, along with the potential for
longer recovery, more incisional pain, greater radiation exposure for operators, unsuitable
delivery catheters for alternative access sites, and a host of unique alternative access
site complications.
We propose to collectively analyze 30-day safety endpoints as a lumped data group for these
alternative access approaches. These data are gathered from clinical practice in real-world
settings and submitted to the TVT Registry. It is expected that centers will choose among
the various choices for alternative access based the causative factors underlying the need
for alternative access, as well as local skill sets and experience. For this lumped data
group of alternative access approaches we will compare 30-day safety results to the TA
outcomes reported from Cohort A of the PARTNERS 1 trial. We recognize that these TA patients
were high risk operable patients rather than inoperable patients, but no other direct
comparator group is available. We reason that the TA data from this published clinical trial
are high quality, represent an alternative access approach rather than TF, and will provide
a frequency of safety endpoints that have been found to be acceptable both clinically and
from a regulatory perspective.
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Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
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Not yet recruiting |
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