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

NCT01694563 | Completed Results

• 1 other identifier: CP2011-1
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 49

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.

Conditions

Persistent Atrial Fibrillation; Longstanding Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Efficacy Outcome

  12, 24, and 36 months post-operatively

Study Arms (1)

Atrial Fibrillation

OTHER

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

Interventions

Synergy Ablation System DEVICE

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.

Also known as: Isolator Synergy Handpieces, Isolator Synergy Clamp

Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (49)

University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Scottsdale Healthcare Clinical Research Institute

Scottsdale, Arizona, 85258, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Cedars-Sinai Medical Center

West Hollywood, California, 90048, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Lee Memorial Hospital

Fort Myers, Florida, 33901, United States

Location

University of Florida Cardiothoracic Surgery

Gainesville, Florida, 32611, United States

Location

Bayfront Medical Center

St. Petersburg, Florida, 33701, United States

Location

Northside Hospital

St. Petersburg, Florida, 33709, United States

Location

James A. Haley Veteran's Hospital/Cardiothoracic Surgery

Tampa, Florida, 33612, United States

Location

Pepin Heart Hospital

Tampa, Florida, 33613, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Northwestern Memorial Hospital

Evanston, Illinois, 60208, United States

Location

SIU- Memorial Medical Center

Springfield, Illinois, 62794, United States

Location

St. Francis Heart Hospital

Indianapolis, Indiana, 46237, United States

Location

Inidiana Heart Center

Indianapolis, Indiana, 46290, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Veteran Affairs Boston Healthcare System

West Roxbury, Massachusetts, 02132, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49506, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48910, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

United Heart & Vascular/Abbott Northwestern Hospital

Minneapolis, Minnesota, 55102, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Nebraska Heart

Lincoln, Nebraska, 68526, United States

Location

St. Joseph's Regional Medical Center

Paterson, New Jersey, 07503, United States

Location

Mission Hospital/Asheville Heart

Asheville, North Carolina, 28803, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Triad Cardiac and Thoracic Surgeons/Cone Health

Greensboro, North Carolina, 27401, United States

Location

Altru Health System

Grand Forks, North Dakota, 58201, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45242, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73135, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Pinnacle Health Hospitals

Harrisburg, Pennsylvania, 17101, United States

Location

Hospital of the University of Pennsylvania (HUP)

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

UT Southwestern University Hospital

Dallas, Texas, 75390, United States

Location

St. Mark's Hospital

Salt Lake City, Utah, 84124, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nfii K. Ndikintum, PhD, MBA / VP, Clinical Affairs and Biometrics
• Organization: Atricure Inc.

NNdikintum@atricure.com

513-644-8192

Study Officials

• Patrick McCarthy, MD

  Chief, Division of Cardiac Surgery, Northwestern University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: September 1, 2012
• Primary Completion: October 23, 2017
• Study Completion: March 21, 2018
• Last Updated: October 9, 2019
• Results First Posted: September 13, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (49)