Market Overview

SentreHEART Announces 400th Patient Enrollment in the Landmark aMAZE Trial

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SentreHEART, Inc., manufacturer of the LARIAT® Suture Delivery Device
(LARIAT) for percutaneous left atrial appendage (LAA) closure announces
enrollment of the 400th patient in the prospective,
multi-center, randomized controlled Trial known as the aMAZE Trial. The
Trial is a superiority design and intends to demonstrate the LARIAT
procedure for LAA closure, when used in adjunct with subsequent
Pulmonary Vein Isolation (PVI) catheter ablation, will lead to a reduced
incidence of recurrent atrial fibrillation (AFib) compared to PVI alone
in those patients that suffer from drug-refractory, persistent and
long-standing persistent AFib.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180905005313/en/

David J. Wilber, MD, FAHA, FACC Loyola University Medical Center (Photo: Business Wire)

David J. Wilber, MD, FAHA, FACC Loyola University Medical Center (Photo: Business Wire)

Dr. David Wilber, aMAZE Study National Co-Principal Investigator (PI)
and Director of Cardiovascular Institute at Loyola Medicine stated "This
is a historic milestone for the aMAZE Trial as defined under the
contemporary, Bayesian trial design. From this point forward a series of
interim analyses are initiated for predictive success while patient
enrollment continues uninterrupted. This trial will change the treatment
paradigm for patients suffering from continuous AFib. Congratulations to
the Investigators and their patients for reaching this significant
milestone in the trial. Together we are one step closer to having
rigorous data to support this potential treatment option."

"It's impressive to see the aMAZE Trial reach this milestone so quickly
and close in on the ultimate finish line," stated Dr. Dhanunjaya
Lakkireddy, National Co-PI of the aMAZE Trial and Medical Director at
Kansas City Heart Rhythm Institute. "This trial will be a game changer
in AFib therapy."

AFib is an irregular heartbeat or quivering of the upper chamber of the
heart called the atria due to a malfunction in the heart's electrical
system. It is the most common sustained arrhythmia and a major global
public health problem due to its associated morbidity, including stroke
and heart failure, diminished quality of life and increased mortality.
Approximately 33.5 million individuals worldwide suffer from AFib, with
close to 5 million new cases occurring each year.

PVI Catheter ablation is the standard of care in the management of
drug-refractory symptomatic AFib. However, the success rates of PVI
ablation are less than ideal, especially in patients with persistent
AFib.1 Current data suggests that a single ablation procedure
of the pulmonary veins (PV) for treating AFib results in long-term
success rates of only 20%-40%. The LAA has been known to play a role in
triggering recurrence of AFib after treatment with PVI catheter
ablation, and is the source of most stroke-causing blood clots
(thrombus) in AFib patients.

Studies have demonstrated the LARIAT not only closes the LAA mechanically2
but may also isolate electrical activity3 within the LAA.
Having a non-implant option that may both electrically and mechanically
isolate the LAA is a potentially important addition to the treatment
armamentarium for clinicians treating patients with persistent or
longstanding persistent AFib. The LARIAT has the potential to
permanently eliminate the LAA as a source of AFib and nidus for thrombus.

Unlike LAA implant solutions for AFib, the aMAZE Trial seeks to
potentially treat an underlying disorder of AFib by mechanically and
electrically isolating the base of the LAA in a single step using the
percutaneous, non-implant LARIAT suture delivery device.

Learn more about the aMAZE Trial, including patient eligibility,
at the following:
https://clinicaltrials.gov/ct2/show/NCT02513797
and https://amazetrial.com

Clinicaltrials.gov Identifier: NCT02513797
U.S. FDA IDE #G150107

About SentreHEART, Inc.

SentreHEART is a privately owned medical device company based in Redwood
City, CA. Founded in 2005, SentreHEART has developed innovative
technology for remote delivery of suture for closure of anatomic
structures including the left atrial appendage.

1. Tilz, R.R., et al., Catheter ablation of long-standing persistent
atrial fibrillation: a lesson from circumferential pulmonary vein
isolation. J Cardiovasc Electrophysiol, 2010. 21(10): p.1085-93
2.
Bartus K, et al. Percutaneous Left Atrial Appendage Suture Ligation
Using the LARIAT Device in Patients with Atrial Fibrillation. J Am Coll
Cardiol 2013 Jul 9; 62(2):108-18
3. Han F, et al. The Effects of
LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70

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