WATCH-TAVR: WATCHMAN™ for patients with atrial fibrillation undergoing transcatheter aortic valve replacement

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

N/A

Background Information

The purpose of this study is to look at the safety and effectiveness of the WATCHMAN™ device procedure when it is done in combination (at the same time) with the TAVR procedure. This combined approach will be compared to the TAVR procedure along with medical treatment only for an extended period of time.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042
Principal Investigator

Wayne Batchelor, MD

Eric Sarin, MD

Eligibility Information

  1. Diagnosed as having atrial fibrillation (AF or AFib) and aortic stenosis (AS) requiring a Transcatheter Aortic Valve Replacement (TAVR)
  2. Documented paroxysmal, persistent, or permanent atrial fibrillation
  3. Patient is eligible to undergo WATCHMAN implantation procedure
  4. Patient is eligible for short term warfarin therapy

Ineligibility Information

  1. Patient had stroke or TIA within 6 months prior to enrollment
  2. Contradiction for short term anticoagulation
  3. Moderate or severe mitral stenosis
  4. Patient had symptomatic carotid disease
  5. Prior occlusion of LAA
  6. Patient has an implanted mechanical mitral valve
  7. Patient requires long-term warfarin therapy due to: prior arterial embolism, pulmonary embolism within previous 6 months.