Persistent Atrial Fibrillation Clinical Trial
— ABLATE-PASOfficial title:
AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery
NCT number | NCT01694563 |
Other study ID # | CP2011-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | March 21, 2018 |
Verified date | March 2018 |
Source | AtriCure, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AtriCure, Inc. |
United States,
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 |
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