The American College of Cardiology (ACC) launched a registry on Dec. 16 to track data on left atrial appendage occlusion (LAAO) devices.
The registry will serve as the FDA-mandated post-approval study for the Watchman device (Boston Scientific), which was approved in March for percutaneous closure of the left atrial appendage and to reduce the risk of stroke in patients with non-valvular atrial fibrillation. The device is intended as an alternative to warfarin or novel anticoagulants.
The ACC said in a news release that the registry “is also expected to serve as a long-term clinical registry for all patients undergoing occlusion of the left atrial appendage, regardless of the device used.” The ACC has nine cardiovascular data registries and plans on launching an atrial fibrillation ablation registry next year.
On Dec. 10, the ACC, Society for Cardiovascular Angiography and the Heart Rhythm Society released a consensus statement on LAAO procedures and devices.
“As this technology becomes clinically available to a broader population of patients, it is essential that physician stakeholders establish criteria for the performance of these procedures that will be used in granting initial and ongoing privileges,” the document’s authors wrote.