ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
- Conditions
- Longstanding Persistent Atrial FibrillationPersistent Atrial Fibrillation
- Interventions
- Device: Synergy Ablation System
- Registration Number
- NCT01694563
- Lead Sponsor
- AtriCure, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atrial Fibrillation Synergy Ablation System 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.
- Primary Outcome Measures
Name Time Method The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks. 36 months post-operatively The number of participants 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 as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Outcome 12, 24, and 36 months post-operatively The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting \> 30 continuous seconds duration of either Atrial Fibrillation, 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.
Trial Locations
- Locations (49)
USC University Hospital
🇺🇸Los Angeles, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Hospital of the University of Pennsylvania (HUP)
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Aspirus Wausau Hospital
🇺🇸Wausau, Wisconsin, United States
Lee Memorial Hospital
🇺🇸Fort Myers, Florida, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
St. Francis Heart Hospital
🇺🇸Indianapolis, Indiana, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
SIU- Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Mission Hospital/Asheville Heart
🇺🇸Asheville, North Carolina, United States
Triad Cardiac and Thoracic Surgeons/Cone Health
🇺🇸Greensboro, North Carolina, United States
Altru Health System
🇺🇸Grand Forks, North Dakota, United States
United Heart & Vascular/Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
James A. Haley Veteran's Hospital/Cardiothoracic Surgery
🇺🇸Tampa, Florida, United States
Pepin Heart Hospital
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Scottsdale Healthcare Clinical Research Institute
🇺🇸Scottsdale, Arizona, United States
University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸West Hollywood, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Inidiana Heart Center
🇺🇸Indianapolis, Indiana, United States
Veteran Affairs Boston Healthcare System
🇺🇸West Roxbury, Massachusetts, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Nebraska Heart
🇺🇸Lincoln, Nebraska, United States
St. Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Pinnacle Health Hospitals
🇺🇸Harrisburg, Pennsylvania, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
UT Southwestern University Hospital
🇺🇸Dallas, Texas, United States
St. Mark's Hospital
🇺🇸Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Northwestern Memorial Hospital
🇺🇸Evanston, Illinois, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Florida Cardiothoracic Surgery
🇺🇸Gainesville, Florida, United States