ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation
NCT ID: NCT01694563
Last Updated: 2019-10-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
365 participants
INTERVENTIONAL
2012-09-30
2018-03-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
NCT01661205
Medtronic Concomitant Utilization of Radio Frequency for Atrial Fibrillation CURE-AF/Persistent
NCT00506493
Medical and Surgical Hybrid Treatment of Atrial Fibrillation.
NCT02630914
Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation
NCT01558635
Concomitant Treatment of Permanent Atrial Fibrillation
NCT00566787
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AtriCure, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick McCarthy, MD
Role: STUDY_CHAIR
Chief, Division of Cardiac Surgery, Northwestern University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
St. Petersburg, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
James A. Haley Veteran's Hospital/Cardiothoracic Surgery
Tampa, Florida, United States
Pepin Heart Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Evanston, Illinois, United States
SIU- Memorial Medical Center
Springfield, Illinois, United States
St. Francis Heart Hospital
Indianapolis, Indiana, United States
Inidiana Heart Center
Indianapolis, Indiana, United States
Maine Medical Center
Portland, Maine, United States
Veteran Affairs Boston Healthcare System
West Roxbury, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
United Heart & Vascular/Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Nebraska Heart
Lincoln, Nebraska, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
Mission Hospital/Asheville Heart
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Triad Cardiac and Thoracic Surgeons/Cone Health
Greensboro, North Carolina, United States
Altru Health System
Grand Forks, North Dakota, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania (HUP)
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
UT Southwestern University Hospital
Dallas, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP2011-1
Identifier Type: -
Identifier Source: org_study_id
NCT01174745
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.