WATCHMAN Implantation During Hybrid Ablation "WINNING"

Recruiting

Phase N/A Results N/A

Trial Description

Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Stroke remains the most feared complication of AF with an increase in risk by 5-fold, and is the leading cause of morbidity and mortality. The left atrial appendage (LAA) is the origin for more than 90% of the emboli in non-valvular AF. The WATCHMANâ„¢ Left Atrial Closure Device (WATCHMAN Device, Boston Scientific) reduces the risk of stroke by closing off the LAA. During hybrid procedures for AF, LAA occlusion with epicardial devices is known to be difficult and not free of risks.It thus will be interesting to study the safety and feasibility of endocardial WATCHMAN Device implantation in a hybrid ablation approach.

Conditions

Interventions

  • WATCHMAN Device impantation Device
    Intervention Desc: The implantation of the device will be done into the left atrial appendage according to the guidelines.
    ARM 1: Kind: Experimental
    Label: WATCHMAN Implantation
  • WATCHMAN Device implantation Device
    Intervention Desc: The implantation of the device will be done into the left atrial appendage according to the guidelines.
    ARM 1: Kind: Experimental
    Label: WATCHMAN Implantation

Trial Design

  • Masking: Open Label
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Major complications during follow-up, assessed by scoring the number of complications 6 months Yes
Primary Device success, assessed by TEE. 6 months No
Primary Device success, assessed by transesophageal echocardiogram. 6 months No

Sponsors