According to a press release, SentreHeart will present recent data regarding the use of its Lariat suture delivery device as a therapeutic and prophylactic solution for patients with atrial fibrillation (aFib) at the Left Atrial Appendage (LAA) conference, Frankfurt, Germany on 20-21st November 2015.
Studies have demonstrated the Lariat device not only closes the left atrial appendage (LAA) mechanically but may also isolate electrical activity within the LAA, according to SentreHeart. SentreHeart has received FDA approval for, and has begun enrolling patients in, the AMAZE study. This research is intended to demonstrate that a Lariat procedure for LAA closure, plus a subsequent PVI catheter ablation, will lead to a reduced incidence of recurrent AFib compared to PVI alone; with a high safety profile.
The study plans to enrol a maximum of 600 persistent or longstanding persistent patients who are candidates for PVI catheter ablation at up to 50 centres across the United States. The first stage of the AMAZE trial is to establish safety and will enrol up to 100 patients at 15 centres.
According to Sentreheart, the Lariat has the potential to eliminate the LAA as a source of AFib and remove it as a nidus for thrombus.
The LAA conference will include the presentation of data which compares leak rates between the LARIAT and Watchman devices.