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

Not Applicable

Completed

• Conditions: Longstanding Persistent Atrial Fibrillation; Persistent Atrial Fibrillation

• 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-27
• Primary Completion: 2017-10-23
• Status Verified: 2018-03
• Study Completion: 2018-03-21
• Results First Submitted: 2018-10-29
• Results First Submitted QC: 2019-09-12
• Results First Posted: 2019-09-13
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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)

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; 🇺🇸 Saint Petersburg, Florida, United States

Scroll for more (39 remaining)