NCT00926783

Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation

Selective CFAE Targeting for Atrial Fibrillation (SELECT-AF)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atrial fibrillation will be considered.) Eligible subjects will be randomized into one of two arms in the study: (1) targeted CFAE ablation or (2) generalized CFAE ablation. Both techniques will then be followed by PVAI (pulmonary vein antral isolation) as part of a hybrid ablation strategy. The nature of the ablation procedures does not allow physicians to be blinded to the randomization.

Detailed description

The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute effects on AFCL (atrial fibrillation cycle length), AF regularization, and AF termination; (2) number and distribution of lesion sets delivered; and (3) long term effects on procedural outcome when combined with PVAI as a hybrid strategy.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	CFAE ablation	CFAE ablation (targeted vs. generalized)

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-11-01
• Completion: 2013-09-01
• First posted: 2009-06-24
• Last updated: 2014-06-10
• Results posted: 2014-06-03

Locations

7 sites across 3 countries: United States, Australia, Canada