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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2018
Source AtriCure, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT01174745

Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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