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Primary Diagnosis

Atrial Fibrillation (AFib)

Study Purpose

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

Trial Details

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

Contact Information:

Destiny Barnett

Penni Dolton

Full Protocol Title

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

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