ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal AF (ABLATE PAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01694563
First received: September 24, 2012
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
Device: Synergy Ablation System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Primary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operatively ] [ Designated as safety issue: No ]
    Proportion of patients 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 (except amiodarone which must be 12 weeks prior to the assessment) as determined by core last assessment of a 48 hour Holter, Zio Patch or PPM interrogation recording performed at a minimum of 12, 24 and 36 months postoperatively (hypothesis test at 36 months).


Secondary Outcome Measures:
  • Secondary Efficacy Outcome [ Time Frame: 12, 24 and 36 months post-operative procedure ] [ Designated as safety issue: No ]
    Proportion of patients free from AF regardless of antiarrhythmic drug usage (i.e., no episodes lasting >30 continuous seconds duration of either AF, 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.

  • Secondary Safety Outcomes [ Time Frame: Through 30 days post-operative or hospital discharge, whichever is later. ] [ Designated as safety issue: Yes ]

    Composite major adverse event: Serious adverse events occuring post-operatively within 30 days post-procedure or hospital discharge (whichever is later) including:

    • death (includes deaths after 30 days or hospital discharge if death is procedure related)
    • Stroke (resulting in significant permanent disability)
    • TIA
    • Myocardial infarction
    • Excessive bleeding (requiring >2 units of blood replacement and surgical intervention).


Other Outcome Measures:
  • Primary Safety Outcomes [ Time Frame: Through 30 days post-operatively or hospital discharge, whichever is later ] [ Designated as safety issue: Yes ]
    Proportion of patients with any serious device or ablation procedure-related adverse events within 30 days post procedure or hospital discharge (whichever is later) as adjudicated by a Clinical Events Committee (CEC).

  • Pacemaker implantation [ Time Frame: within 30 days post-procedure ] [ Designated as safety issue: Yes ]
    Pacemaker implantation within 30 days post-procedure will be summary and reported by reason for PPM.


Enrollment: 365
Study Start Date: September 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 contined safety and efficacy during the peri-procedureal and long term phase during commercial use.
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.
Other Names:
  • Synergy Ablation System
  • Isolator Synergy Handpieces
  • Isolator Synergy Clamp

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a history of non-paroxysmal forms of atrial fibrillation (AF), persistent or longstanding persistent, who are undergoing an elective open cardiac surgical procedure.

Criteria

Inclusion Criteria:

  • Age > or equal to 18 years of age
  • History of non-paroxysmal form of AF as defined by the HRS/EHRA/ECAS 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 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 th e results of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694563

  Hide Study Locations
Locations
United States, Alabama
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Scottsdale Healthcare Clinical Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
USC University Hospital
Los Angeles, California, United States, 90033
Sharp Memorial Hospital
San Diego, California, United States, 92123
Cedars-Sinai Medical Center
West Hollywood, California, United States, 90048
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Lee Memorial Hospital
Fort Myers, Florida, United States, 33901
University of Florida Cardiothoracic Surgery
Gainesville, Florida, United States, 32611
Bayfront Medical Center
Saint Petersburg, Florida, United States, 33701
Northside Hospital
Saint Petersburg, Florida, United States, 33709
James A. Haley Veteran's Hospital/Cardiothoracic Surgery
Tampa, Florida, United States, 33612
Pepin Heart Hospital
Tampa, Florida, United States, 33613
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30308
United States, Illinois
Northwestern Memorial Hospital
Evanston, Illinois, United States, 60208
SIU- Memorial Medical Center
Springfield, Illinois, United States, 62794
United States, Indiana
Inidiana Heart Center
Indianapolis, Indiana, United States, 46290
St. Francis Heart Hospital
Indianapolis, Indiana, United States, 46237
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Veteran Affairs Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Spectrum Health
Grand Rapids, Michigan, United States, 49506
Sparrow Clinical Research Institute
Lansing, Michigan, United States, 48910
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
United Heart & Vascular/Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55102
United States, Missouri
Missouri Baptist Medical Center
St. Louis, Missouri, United States, 63131
Washington University
St. Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Heart
Lincoln, Nebraska, United States, 68526
United States, New Jersey
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
United States, North Carolina
Mission Hospital/Asheville Heart
Asheville, North Carolina, United States, 28803
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Triad Cardiac and Thoracic Surgeons/Cone Health
Greensboro, North Carolina, United States, 27401
United States, North Dakota
Altru Health System
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45242
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73135
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, United States, 17101
Hospital of the University of Pennsylvania (HUP)
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
UT Southwestern University Hospital
Dallas, Texas, United States, 75390
United States, Utah
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Study Chair: Patrick McCarthy, MD Chief, Division of Cardiac Surgery, Northwestern University
  More Information

No publications provided

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01694563     History of Changes
Obsolete Identifiers: NCT01174745
Other Study ID Numbers: CP2011-1
Study First Received: September 24, 2012
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 29, 2015