Outcomes 2019 - Baylor Scott & White Heart and Vascular Hospital BSWHHVH_646_2019 Outcomes JOOMAG MOD | Page 72

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Top enrolling studies* Cardiac Imaging Core Laboratory
The following studies were top enrolling in fiscal
year 2019 on the Dallas campus. Baylor Scott & White Research Institute
continues to expand the Cardiac Imaging Core
Laboratory Services for the consolidation,
tracking and monitoring of data for cutting-
edge worldwide clinical research trials. Services
include echocardiography, cardiac CT and
cardiac MR imaging modalities.
Led by Paul Grayburn, MD, FACC, the team helps
advance cardiovascular care through data
collection and analysis. Analysis is based on
American Society of Echocardiography (ASE)
recommendations for its services and protocols
are adapted to specific needs of investigators.
ALLOMAP - The purpose of this study is to
observe short and long-term clinical outcomes
in heart transplant recipients who receive
regular AlloMap testing as part of allograft
rejection surveillance, sponsored by CareDX.
Number one ranked enrollment site in the world.
DREAM - The primary objective of this study is to
determine whether transendocardial delivery of
allogeneic human bone marrow-derived MPCs
(rexlemestrocel-L) is effective in the treatment
of chronic heart failure due to LV systolic
dysfunction. (Closed in December 2018.)
EVOLVE 48 - A trial of early discontinuation of
antiplatelets for patients treated with the Boston
Scientific SYNERGY stent. Top-ranked worldwide
enrollment site.
INVESTED - This study tests the hypothesis that
high dose trivalent influenza vaccine will reduce
cardiopulmonary events to a greater extent than
a standard dose quadrivalent influenza vaccine
in high-risk cardiovascular patients with a recent
history of myocardial infarction or heart failure.
ONYX ONE CLEAR - The purpose of this study is
to evaluate the clinical safety and effectiveness
of the Resolute Onyx stent in subjects deemed
at high risk for bleeding and/or medically
unsuitable for more than one month DAPT
treatment receiving reduced duration (one
month) of DAPT following stent implantation.
SPYRAL ON MED - The purpose of this study is
to obtain an assessment of the efficacy and
safety of renal denervation in the presence of
three standard antihypertensive medications,
sponsored by Medtronic Vascular. Top-ranked
nationally for enrollment.
SPYRAL OFF MED - A global clinical study of renal
denervation with the Symplicity Spyral multi-
electrode renal denervation system in patients
with uncontrolled hypertension in the absence
of antihypertensive medications. Top-ranked
nationally for enrollment.
*In the top ten enrollment sites.
New in fiscal year 2019 are the additions of two
Early Feasibility Studies (EFS) which offer a first-
look at the implantation of a new, percutaneously
delivered transcatheter mitral valve replacement
(TMVR), called the Cardiovalve, in humans. This
valve is delivered to the heart by access through
the femoral artery and guiding the valve using
a specialized catheter delivery system in the
cardiac catheterization lab. If successful, the
valve could offer a safe and effective alternative
to open heart surgical mitral valve replacement
in certain patient populations.
Key studies for fiscal year 2019 include:
• AHEAD US/AHEAD EU – US and European EFS
for the Cardiovalve percutaneously delivered
transcatheter mitral valve replacement
(TMVR) via the femoral artery.
• NeoChord/ReChord – Artificial mitral valve
chordal implant repair via percutaneous
apical approach compared to traditional
open surgical repair for degenerative mitral
valve disease.
• SITRAL – Surgical implantation of Sapien
XT valves in patients with severe mitral
annulus calcium.
Paul A. Grayburn, MD, FACC
Medical Director, Cardiac Imaging
Core Laboratory - Baylor Scott &
White Research Institute; Medical
Director, Non-Invasive Cardiology
- Baylor Scott & White Heart and
Vascular Hospital - Dallas; Medical
Director, Cardiology Research and Education -
Baylor University Medical Center