News | Left Atrial Appendage (LAA) Occluders | January 06, 2017

SentreHeart Completes Stage I Enrollment in aMAZE Trial

Trial designed to assess safety and performance of Lariat suture delivery system for treatment of atrial fibrillation in first 100 consecutively enrolled subjects

SentreHeart, Lariat Suture Delivery Device, aMAZE Trial, Stage I, enrollment complete

January 6, 2017 — SentreHeart Inc. announced that it has completed the Stage I enrollment milestone in the aMAZE Trial. The trial aims to assess improved outcomes when the Lariat Suture Delivery System (Lariat) is used to close the left atrial appendage (LAA) in adjunct to pulmonary vein isolation (PVI) catheter ablation in those patients that suffer from drug-refractory, persistent and long-standing persistent atrial fibrillation (AFib).

Stage I of the aMAZE Trial is designed to assess safety and performance of the Lariat procedure in the first 100 consecutively enrolled subjects, assessed by independent adjudication and data monitoring committees. The first subject was enrolled in October 2015 and the trial is currently recruiting subjects in 34 U.S. centers. It is anticipated that by mid-2017, the trial will expand to 50 centers across the United States, and in limited international locations.

AFib is an irregular, rapid heartbeat or quivering of the upper chambers 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.

Studies have demonstrated the LARIAT not only closes the LAA mechanically1 but may also isolate electrical activity within the LAA2. 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 eliminate the LAA as a source of AFib and nidus for thrombus.

Unlike other implant solutions for AFib, the aMAZE Trial seeks to potentially treat the underlying disorder of AF by mechanically and electrically isolating the base of the LAA using the percutaneous, non-implant Lariat suture delivery device.

For more information: www.sentreheart.com

References

1 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

2 Han FT, et al. The Effects of LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70

Related Content

common adult CT examinations, computed tomography, diagnostic reference levels, DRLs, radiation dose, achievable dose, AD
News | Radiation Dose Management| February 23, 2017
Using data from the world’s largest computed tomography (CT) dose index registry, researchers have established national...
News | Cardiac Diagnostics| February 17, 2017
Levels of a protein in the blood associated with heart disease are also linked to early-stage brain damage, according...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems| February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Arterial Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Biotronik, ProMRI Configurator tool, MR-conditional cardiac devices, ProMRI SystemCheck
Technology | Implantable Cardiac Monitor (ICM)| February 14, 2017
Biotronik has developed an online tool that streamlines the workflow for physicians selecting the right magnetic...
News | Hypertension| February 13, 2017
Vascular Dynamics Inc. (VDI) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s...
Xarelto, rivaroxaban, COMPASS study, ends early,
News | Antiplatelet and Anticoagulation Therapies| February 09, 2017
February 9, 2017 — Janssen Research & Development LLC (Janssen) announced that the Phase 3 COMPASS trial is stopp
Medtronic, IDE approval, IN.PACT Admiral drug-coated balloon, DCB, end-stage renal disease
News | Drug-Eluting Balloons| February 08, 2017
Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration...
CSI, LIBERTY 360 Study, ISET 2017, six-month data, lower extremity PAD
News | Atherectomy Devices| February 08, 2017
February 8, 2017 — Cardiovascular Systems (CSI) presented six-month data from its LIBERTY 360° post-market study in a
Penn Medicine, heart failure causes, YAP and TAZ proteins, Journal of Clinical Investigation study
News | Heart Failure| February 07, 2017
February 7, 2017 — Of the more than 700,000 Americans who suffer a heart attack each year, about a quarter go on to d
Overlay Init