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

Persistent Atrial Fibrillation Clinical Trial

— ABLATE-PAS  

Official title:

AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694563
• Other study ID #: CP2011-1
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: March 21, 2018

Study information

• Verified date: March 2018
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01174745

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: March 21, 2018
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Longstanding Persistent Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• Synergy Ablation System
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	36 months post-operatively
Secondary	Secondary Efficacy Outcome	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.	12, 24, and 36 months post-operatively