Atrial Fibrillation (AFib)
Use of the WATCHMAN™ device without anticoagulant therapy
Current U.S. indications for WATCHMAN left atrial appendage closure (LAAC) requires short term use of warfarin anticoagulation generally for a minimum of 45-60 days. Many patients cannot tolerate even short-term use of oral anticoagulation (OAC). Antiplatelet therapies (aspirin and/or clopidogrel) are known not to prevent stroke for atrial fibrillation patients, leaving many patients essentially untreated. ASAP-TOO is a 2:1 randomization of WATCHMAN LAAC versus standard care in patients who are unsuitable for OAC. The trial seeks to demonstrate that the WATCHMAN device is better than no therapy in these currently untreated patients.
Principal Investigator: Steven Kindsvater, MD
Participating Physicians: Srini Potluri, MD / Pedro Nosnick, MD / Deepika Gopal, MD / J. Brian DeVille, MD / Molly Szerlip, MD / Mustafa Dohadwala, MD
Locations: Baylor Scott & White The Heart Hospital – Plano, The Heart Group, Arrhythmia Management, Legacy Heart Center, Pedro Nosnick-Neurology
Sponsor: Boston Scientific
IRB Number: 017-137
Trial Status: Enrolling
Exclusions: Adults only
Change in Care: Participating may change your care
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)
Get Detailed Information On Clinicaltrials.gov »
Physicians are members of the medical staff at one of Baylor Health Care System's subsidiary, community or affiliated medical centers and are neither employees nor agents of those medical centers, Baylor Scott & White The Heart Hospital – Plano or Baylor Health Care System.