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

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

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.

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation
• Intervention / Treatment: Device: Synergy Ablation System

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.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare Clinical Research Institute
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • USC University Hospital
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • West Hollywood, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Lee Memorial Hospital
    • Gainesville, Florida, United States, 32611
      • University of Florida Cardiothoracic Surgery
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront Medical Center
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Tampa, Florida, United States, 33612
      • James A. Haley Veteran's Hospital/Cardiothoracic Surgery
    • Tampa, Florida, United States, 33613
      • Pepin Heart Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern Memorial Hospital
    • Springfield, Illinois, United States, 62794
      • SIU- Memorial Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • St. Francis Heart Hospital
    • Indianapolis, Indiana, United States, 46290
      • Inidiana Heart Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • West Roxbury, Massachusetts, United States, 02132
      • Veteran Affairs Boston Healthcare System
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49506
      • Spectrum Health
    • Lansing, Michigan, United States, 48910
      • Sparrow Clinical Research Institute
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55102
      • United Heart & Vascular/Abbott Northwestern Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart
  • New Jersey
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Regional Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Mission Hospital/Asheville Heart
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Greensboro, North Carolina, United States, 27401
      • Triad Cardiac and Thoracic Surgeons/Cone Health
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Toledo, Ohio, United States, 43606
      • Toledo Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health Hospitals
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania (HUP)
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern University Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • St. Mark's Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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.; Other Names: Isolator Synergy Handpieces; Isolator Synergy Clamp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Study Chair: Patrick McCarthy, MD, Chief, Division of Cardiac Surgery, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): October 23, 2017
• Study Completion (Actual): March 21, 2018

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CP2011-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No