The Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO) trial

Publication date: Available online 15 March 2017 Source:American Heart Journal Author(s): David R. Holmes, Vivek Y. Reddy, Maurice Buchbinder, Kenneth Stein, Myriah Elletson, Martin W. Bergmann, Boris Schmidt, Jacqueline Saw Background Oral anticoagulants (OACs) reduce stroke risks with nonvalvular atrial fibrillation (AF); however, they are underused because of absolute or relative contraindications due to real or perceived risk of bleeding. Although left atrial appendage closure is increasingly performed in OAC-ineligible patients, this has not been studied in a randomized controlled trial. Study objectives The ASAP-TOO study is designed to establish the safety and effectiveness of the Watchman left atrial appendage closure device in patients with nonvalvular AF who are deemed ineligible for OAC. The primary effectiveness end point is the time to first occurrence of ischemic stroke or systemic embolism. The primary safety end point includes all-cause death, ischemic stroke, systemic embolism, or device- or procedural-related event requiring open cardiac surgery or major endovascular intervention. Study design This is a multinational, multicenter prospective randomized trial. Patients meeting the inclusion criteria with CHA2DS2-VASc score≥2 and who are deemed by 2 study physicians to be unsuitable for OAC will be randomized in a 2:1 allocation ratio to Watchman versus control. Control patients will be prescribed single antiplatelet therapy or no therapy at the ...

Source: American Heart Journal - March 15, 2017 Category: Cardiology Source Type: research