ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation

Completed · Not applicable

Conditions studied: Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01694563

Run by

AtriCure, Inc.

People needed

365

Starts

2012-09-01

Expected to finish

2018-03-21

Last updated by the study team

2019-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > or equal to 18 years of age
• History of non-paroxysmal form of Atrial Fibrillation (AF) as defined by the Heart Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society 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 Institutional Review Board (IRB) approved informed consent form.
• Willing and able to return for scheduled follow up visits.

You may not qualify if…

• 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.

Where it is running

• University of Alabama-Birmingham — Birmingham, Alabama, United States
• Scottsdale Healthcare Clinical Research Institute — Scottsdale, Arizona, United States
• USC University Hospital — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Cedars-Sinai Medical Center — West Hollywood, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Lee Memorial Hospital — Fort Myers, Florida, United States
• University of Florida Cardiothoracic Surgery — Gainesville, Florida, United States
• Bayfront Medical Center — St. Petersburg, Florida, United States
• Northside Hospital — St. Petersburg, Florida, United States
• James A. Haley Veteran's Hospital/Cardiothoracic Surgery — Tampa, Florida, United States
• Pepin Heart Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Evanston, Illinois, United States
• SIU- Memorial Medical Center — Springfield, Illinois, United States
• St. Francis Heart Hospital — Indianapolis, Indiana, United States
• Inidiana Heart Center — Indianapolis, Indiana, United States
• Maine Medical Center — Portland, Maine, United States
• Veteran Affairs Boston Healthcare System — West Roxbury, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States

Full record on ClinicalTrials.gov

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