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

BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System
News | Stem Cell Therapies| September 26, 2017
BioCardia Inc. recently announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the...
News | Vena Cava Filters| September 26, 2017
September 26, 2017 — The one-year results of the SENTRY...
Treatment of Heart Attack Patients Depends on Cancer History
News | Cardio-oncology| September 26, 2017
Treatment of heart attack patients depends on their history of cancer, according to research published recently in...
CardiAMP Heart Failure Trial Design Presented at Texas Heart Institute Symposium
News | Heart Failure| September 25, 2017
BioCardia Inc. announced the trial design for its pivotal Phase III CardiAMP Heart Failure Trial was presented during...
Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Overlay Init