ATRICURE SYNERGY ABLATION LESIONS FOR NON-PAROXYSMAL FORMS OF ATRIAL FIBRILLATION TREATMENT DURING CONCOMITANT ON-PUMP ENDO/EPICARDIAL CARDIAC SURGERY

Study ID
STU 082012-065

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • Parkland Health & Hospital System

Contact
Sangita Sethuram
214-645-7728
sangita.sethuram@utsouthwestern.edu

Principal Investigator
Michael Jessen

Summary

Concise Summary:
The aBLaTe Post-approval Study (aBLaTe PaS) is a multi-center, prospective, observational study designed to evaluate the atriCure Synergy ablation System (aSaS) for continued safety and efficacy during commercial use in a real world settings in patients with non-paroxysmal forms of atrial fibrillation. one of the goals of a post approval study is to assure that the provider and subject population are representative of the general population.
Patients who are scheduled to undergo the MaZe iV procedure, using the atricure Synergy ablation System (aSaS) and meet the inclusion criteria will be asked to take part in this post-approval study. There will be no randomization.

The aBLaTe Post-approval Study (aBLaTe PaS) will utilize a 48 hour Holter, Zio[TM] Patch or PPM interrogation performed at follow up (12, 24 and 36 month post-procedure interval) to assess efficacy (i.e. freedom from aF). This holter is provided by the sponsor. additionally, secondary efficacy outcomes will be reported through 36 months post-operatively. The Holter Monitor, Zio[TM] Patch or PPM interrogation data shall be reviewed by an independent Core Laboratory

Participant Eligibility

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Age >= 18 years

* History of a non-paroxysmal form of atrial fibrillation as defined by the HRS/EHRA/ECAS Consensus Statement.

* Persistent AF shall be defined as continuous AF that is sustained beyond seven days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after > 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.

* Longstanding persistent AF shall be defined as continuous AF of greater than 12 months duration. The performance of a successful cardioversion (sinus rhythm >30 seconds) within 12 months of an ablation procedure with documented early recurrence of AF with 30 days should not alter the classification of AF as long-standing persistent.

Note: For both types of AF, two (2) electrocardiograms (e.g. 12-lead ECG, Holter, event monitor, Implantable Loop Recorder (ILR), Pacemaker, Zio(TM) Patch, etc.) documenting AF, with electrocardiograms taken at least 7 days apart, for subjects with sustained AF >=7 days. Holter, event monitor, ILR, Zio(TM) Patch or pacemaker recordings need to show continuous AF.


* Subject is scheduled to undergo elective open cardiac surgical procedure(s) to be performed on cardiopulmonary bypass for one or more of the following: Coronary Artery Bypass Grafting, Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement. In conjunction with these procedures patent foramen ovale (PFO) or atrial septal defect (ASD) repair are allowed.

* The patient (or their legally authorized representative) agrees to participate in this study by signing the IRB approved informed consent form.

* Willing and able to return for scheduled follow-up visits.