ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal AF (ABLATE PAS)
The primary objective of this post-approval study is to evaluate the clinical outcomes in a cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation System by physicians performed the Maze IV procedure.
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Device: Synergy Ablation System
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery|
- Primary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operatively ] [ Designated as safety issue: No ]Proportion of patients free from atrial fibrillation (AF), i.e., episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks (except amiodarone which must be 12 weeks prior to the assessment) as determined by core last assessment of a 48 hour Holter, Zio Patch or PPM interrogation recording performed at a minimum of 12, 24 and 36 months postoperatively (hypothesis test at 36 months).
- Secondary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operative procedure ] [ Designated as safety issue: No ]Proportion of patients free from AF regardless of antiarrhythmic drug usage (i.e., no episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia) as determined by an independent core lab assessment of 48 hour Holter, Zio Patch or PPM interrogation recording performed at a minimum of 12, 24 and 36 months post-operatively.
- Secondary Safety Outcomes [ Time Frame: Through 30 days post-operative or hospital discharge, whichever is later. ] [ Designated as safety issue: Yes ]
Composite major adverse event: Serious adverse events occuring post-operatively within 30 days post-procedure or hospital discharge (whichever is later) including:
- death (includes deaths after 30 days or hospital discharge if death is procedure related)
- Stroke (resulting in significant permanent disability)
- Myocardial infarction
- Excessive bleeding (requiring >2 units of blood replacement and surgical intervention).
- Primary Safety Outcomes [ Time Frame: Through 30 days post-operatively or hospital discharge, whichever is later ] [ Designated as safety issue: Yes ]Proportion of patients with any serious device or ablation procedure-related adverse events within 30 days post procedure or hospital discharge (whichever is later) as adjudicated by a Clinical Events Committee (CEC).
- Pacemaker implantation [ Time Frame: within 30 days post-procedure ] [ Designated as safety issue: Yes ]Pacemaker implantation within 30 days post-procedure will be summary and reported by reason for PPM.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for contined safety and efficacy during the peri-procedureal and long term phase during commercial use.
Device: Synergy Ablation System
Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:
This prospective, open label, multi-center, observational, single arm registry is designed to monitor the AtriCure Synergy Ablation System continued safety and efficacy during the peri-procedural and long-term phase during commercial use in patients being treated for non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump cardiac surgical procedure.
|Contact: Shana Zinkfirstname.lastname@example.org|
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|Study Chair:||Patrick McCarthy, MD||Chief, Division of Cardiac Surgery, Northwestern University|