US-based medical device firm SentreHeart has completed patient enrolment in stage I of its aMAZE trial for LARIAT Suture Delivery System (LARIAT).
The aMAZE trial evaluates the outcomes of LARIAT in closure of left atrial appendage in combination with pulmonary vein isolation catheter ablation, in patients with drug-refractory, persistent and long-standing persistent AFib.
Stage I of the trial examines the safety and performance of the LARIAT procedure in the first 100 consecutively enrolled subjects.
With the first subject enrolled in October 2015, the firm is currently enlisting subjects at 34 US centres, with plans to expand to 50 centres.
SentreHeart chief executive officer and president Russ Seiber said: “We are delighted by the enrolment progress of the aMAZE Trial and are excited have achieved our 2016 enrollment objectives.
“The rapid completion of this significant enrolment milestone demonstrates that clinicians and patients are seeking new therapeutic options for the treatment of persistent and long-standing persistent AFib.”
AFib is an irregular, rapid heartbeat of the heart's atria caused due to a malfunction in the organ's electrical system.
The studies conducted indicate that LARIAT closes the LAA mechanically as well as isolates electrical activity within the LAA, which can be used to treat patients with persistent or longstanding persistent AFib.
The LARIAT can remove LAA as a source of AFib and nidus for thrombus.
In the trial, the percutaneous, non-implant LARIAT suture delivery device is used to treat AF by mechanically and electrically isolating the base of the LAA
SentreHeart intends to enroll a total of approximately 600 patients for the aMAZA trial.