MARLBOROUGH, Mass.,
Oct. 29, 2020 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) has initiated the CHAMPION-AF
clinical trial to evaluate the safety and efficacy of the WATCHMAN
FLX™ Left Atrial Appendage Closure (LAAC) Device within a broad
population of patients with non-valvular atrial fibrillation
(NVAF), including those who are at low-to-moderate risk of bleeding
from the use of anticoagulation. The device will be compared to
treatment with non-vitamin K antagonist oral anticoagulants
(NOACs), considered the leading contemporary drugs for stroke risk
reduction in this population.
Approximately 33 million people worldwide have AF, a common
heart rhythm disorder, which makes them five times more likely to
have a stroke than someone with a normal heart
rhythm.1,2 In patients with NVAF, more than 90% of
heart-related blood clots form in the left atrial
appendage.3 The WATCHMAN FLX device is designed to close
off this area of the heart permanently, providing a one-time
solution for those who need an alternative to anticoagulation to
reduce their risk of stroke.
The randomized CHAMPION-AF trial will enroll 3,000 patients with
NVAF who are suitable for oral anticoagulation therapy across a
broad spectrum of stroke and bleeding risk. Patients at
approximately 150 global sites will be randomized to receive the
newest-generation WATCHMAN FLX device or a NOAC and will be
followed for five years. The trial will evaluate the rates
of cardiovascular death, stroke, systemic embolism and
post-procedural major or clinically relevant non-major
bleeding.
"The CHAMPION-AF trial will compare the WATCHMAN FLX device in a
head-to-head fashion against best-in-class pharmacological therapy
for stroke prevention and evaluate the technology as a first-line
therapy for those who can tolerate anticoagulation," said Dr.
Ian Meredith, global chief medical
officer, Boston Scientific. "A positive outcome for this study
has the potential to change clinical practice and expand device
access to more patients who would benefit from a one-time
procedural alternative to the long-term use of blood thinners and
their potential side effects, including those patients at
low-to-moderate bleeding risk."
The first patient was enrolled this week by Dr. Devi Nair, director, Cardiac Electrophysiology
Division, St. Bernards Heart & Vascular Center. The co-chairs
for the trial are Dr. Marty Leon,
director, Center for Interventional Vascular Therapy, New
York-Presbyterian Heart Valve Center/Columbia
University Irving Medical Center; and Dr. Kenneth A. Ellenbogen, chair, Division of
Cardiology and Kimmerling professor, Virginia
Commonwealth University. Dr. Saibal
Kar, physician director, Interventional Cardiology, HCA
Healthcare and director, Structural Heart Disease Intervention and
Research, Los Robles Health System; and Dr. Shephal Doshi,
director, Cardiac Electrophysiology, Pacific Heart Institute and
Providence St. John's Health Center, will serve as the principal
investigators.
The CHAMPION-AF trial will add to the body of clinical evidence
for the WATCHMAN FLX device, along with PINNACLE FLX and the
currently-enrolling OPTION trial, a randomized controlled study
comparing the device to oral anticoagulants – including but not
limited to NOACs – in patients with non-valvular AF who also
undergo a cardiac ablation procedure.
The WATCHMAN FLX technology includes new features offering
physicians the ability to safely enter, and maneuver within, the
left atrial appendage and is the first LAAC device that can be
fully recaptured, repositioned and redeployed for precise
placement. This next-generation device – which received FDA
approval in July 2020 and CE Mark in
March 2019 – is also available in
broader size options than the previous generation device and can
treat a wider range of patient anatomies. The original WATCHMAN
device has been implanted in more than 100,000 patients
worldwide.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for 40 years, we advance science
for life by providing a broad range of high performance solutions
that address unmet patient needs and reduce the cost of healthcare.
For more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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CONTACTS:
Angela Mineo
Media Relations
(763) 955-8325 (office)
Angela.Mineo@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com
1 Chugh SS, et al. Worldwide epidemiology of atrial
fibrillation: a global burden of disease 2010 study. Circulation
2014;129:837–847. doi:
https://doi.org/10.1161/CIRCULATIONAHA.113.005119.
2 Atrial Fibrillation Fact Sheet." Centers for
Disease Control and Prevention.
http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm.
3 Blackshear JL, Odell JA. Appendage obliteration to
reduce stroke in cardiac surgical patients with atrial
fibrillation. Ann Thorac Surg. 1996;61:755-759.
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SOURCE Boston Scientific Corporation