Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE) "EVOLVE"

Completed

Phase N/A Results N/A

Trial Description

This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Conditions

Interventions

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Successful implantation of the next generation WATCHMAN device without the occurance of life-threatening events caused by the device and/or procedure. 12-Months Yes
Primary Device Success Implant through 45-Days No

Sponsors