Clinical trial NCT01694563: ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
Official title: AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: 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.
timeFrame: 36 months post-operatively
Secondary outcomes:
measure: Secondary Efficacy Outcome
timeFrame: 12, 24, and 36 months post-operatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Clinical Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Fort Myers
country: United States
facility: Lee Memorial Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida Cardiothoracic Surgery
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veteran's Hospital/Cardiothoracic Surgery
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Evanston
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Springfield
country: United States
facility: SIU- Memorial Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Francis Heart Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Inidiana Heart Center
state: Indiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: West Roxbury
country: United States
facility: Veteran Affairs Boston Healthcare System
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: United Heart & Vascular/Abbott Northwestern Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart
state: Nebraska
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Asheville
country: United States
facility: Mission Hospital/Asheville Heart
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Triad Cardiac and Thoracic Surgeons/Cone Health
state: North Carolina
city: Grand Forks
country: United States
facility: Altru Health System
state: North Dakota
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania (HUP)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern University Hospital
state: Texas
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
Study officials:
affiliation: Chief, Division of Cardiac Surgery, Northwestern University
name: Patrick McCarthy, MD
role: STUDY_CHAIR
References: