A Phase 3 interventional study of AtriCure Bipolar System in Atrial Fibrillation, sponsored by AtriCure, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-21.
Sponsored by AtriCure, Inc. · Phase 3 and Interventional
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
Browse Atrial Fibrillation studies →AtriCure, Inc. is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Exclusion Criteria:
The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
No study locations are listed for this record.
This study is withdrawn, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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AtriCure, Inc.