Atrial Fibrillation

  • STATUS
    Not Recruiting
  • sponsor
    Atricure
Updated on 3 March 2021
bypass graft
fibrillation
cardiopulmonary bypass
paroxysmal atrial fibrillation
pulmonary vein isolation
mitral valve repair
tricuspid valve repair

Summary

Study Description:

Atrial Fibrillation
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 continued safety and efficacy during the peri-procedural and long term phase during commercial use.
Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:
•Coronary Artery Bypass Grafting (CABG)
•Mitral valve repair or replacement
•Aortic valve repair or replacement
•Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.

Description

Eligibility Criteria:

Inclusion Criteria:
•Age > or equal to 18 years of age

•History of non-paroxysmal form of AF 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 greater than or equal to 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 longstanding persistent.

•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 procedure 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 singing the IRB approved informed consent form.
•Willing and able to return for scheduled follow up visits.

Exclusion Criteria:
•Stand along AF without indication(s) for concomitant cardiac surgery.
•Need for emergent cardiac surgery (i.e., cardiogenic shock).
•Preoperative need for an intra-aortic balloon pump or intravenous inotropes.
•Pregnancy or desire to get pregnant for the duration of the study concomitant surgical procedure through the thirty six (36) month follow up period).
•Enrolled in another clinical trial that could confound the results of this study.

Details
Condition Cardiac ablation, Atrial Fibrillation, VALVULAR HEART DISEASE, Atrial Fibrillation (Pediatric), Heart Valve Disease
Clinical Study IdentifierTX133778
SponsorAtricure
Last Modified on3 March 2021

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