David R Holmes1, Vivek Y Reddy2, Maurice Buchbinder3, Kenneth Stein4, Myriah Elletson4, Martin W Bergmann5, Boris Schmidt6, Jacqueline Saw7. 1. Mayo Clinic, Rochester, MN. 2. Icahn School of Medicine at Mount Sinai, New York, NY. 3. Stanford University, Stanford, CA. 4. Boston Scientific Corp., Minneapolis, MN. 5. Herzkatheter Asklepios Wandsbek, Hamburg, Germany. 6. Cardioangiologisches Centrum Bethanien, Frankfurt, Germany. 7. Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address: jsaw@mail.ubc.ca.
Abstract
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 discretion of the study physician. Up to 888 randomized subjects will be enrolled from up to 100 global investigational sites. Both device group and control patients will have follow-up visits at 3, 6, and 12months and then every 6months through 60months. SUMMARY: This trial will assess the safety and efficacy of Watchman in this challenging population of high-stroke risk AF patients.
RCT Entities:
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 discretion of the study physician. Up to 888 randomized subjects will be enrolled from up to 100 global investigational sites. Both device group and control patients will have follow-up visits at 3, 6, and 12months and then every 6months through 60months. SUMMARY: This trial will assess the safety and efficacy of Watchman in this challenging population of high-stroke risk AFpatients.
Authors: Benjamin A Steinberg; Nicholas G Ballew; Melissa A Greiner; Steven J Lippmann; Lesley H Curtis; Emily C O'Brien; Manesh R Patel; Jonathan P Piccini Journal: JACC Clin Electrophysiol Date: 2019-10-02
Authors: Steffen Schoen; Marian Christoph; Lucie Kretzler; Christoph Mues; Carsten Wunderlich; Anke Langbein; S G Spitzer; Ulrich Gerk; Sebastian Schellong; Thomas Ketteler; Hans Neuser; Marcus Schwefer; Ruth Strasser; Karim Ibrahim Journal: BMC Cardiovasc Disord Date: 2022-06-16 Impact factor: 2.174