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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01694563
First received: September 24, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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.


Estimated Enrollment: 350
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (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

Contacts
Contact: Shana Zink 513-755-4562 szink@atricure.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama-Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Katerine Miller, RN    205-975-3525    kath@uab.edu   
Principal Investigator: Spencer Melby, MD         
United States, Arizona
Scottsdale Healthcare Clinical Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: JoAnne Saczynski, RN, CCRC    480-323-3390    jsaczynski@shc.org   
Principal Investigator: Robert Riley, MD         
United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Msgana Tamrat    310-825-1407    mtamrat@mednet.ucla.edu   
Principal Investigator: Richard Shemin, MD         
USC University Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Becky Lopez    323-442-5849    becky.lopez@med.usc.edu   
Principal Investigator: Vaughn Starnes, MD         
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Chris Kohlmyer    858-244-6886    ckohlmyer@sdcardiac.com   
Contact: Janet Werner    858-244-8875    JWerner@sdcardiac.com   
Principal Investigator: Walter Dembitsky, MD         
Cedars-Sinai Medical Center Recruiting
West Hollywood, California, United States, 90048
Contact: William Woods    310-423-1189    william.woods@cshs.org   
Contact: Tracey Gerez, MA       tracey.gerez@cshs.org   
Principal Investigator: Ali Khoynezhad, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Deborah Katten, RN    860-545-1537    dkatten@harthosp.org   
Principal Investigator: Robert Hagberg, MD         
United States, Florida
Lee Memorial Hospital Recruiting
Fort Myers, Florida, United States, 33901
Contact: Lee Lucas, PhD    239-343-8834    lee.lucas@leememorial.org   
Principal Investigator: Brian Hummel, MD         
University of Florida Cardiothoracic Surgery Recruiting
Gainesville, Florida, United States, 32611
Contact: Debbie Robertson, RN    352-273-5510    debra.robertson@surgery.ufl.edu   
Contact: Nancy Staples, RN    3522735496      
Principal Investigator: Thomas Beaver, MD         
Northside Hospital Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Heather Harteneck, RN    727-521-5392    heather.harteneck@scresearch.net   
Contact: Lauren Kollinger    6153297290    lauren.kollinger@scresearch.net   
Principal Investigator: Michael DeFrain, MD         
Bayfront Medical Center Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Kim Delmontagne, RN    727-527-9779    kdelmontagne@heartsurgery-csa.com   
Contact: Keith Elsworth, RN    7275279779      
Principal Investigator: Hugh van Gelder, MD         
James A. Haley Veteran's Hospital/Cardiothoracic Surgery Recruiting
Tampa, Florida, United States, 33612
Contact: Ileana Fernandez, MSN,RN-BC    813-972-7669    Ileana.Fernandez2@va.gov   
Principal Investigator: Ernesto Jimenez, MD         
Pepin Heart Hospital Recruiting
Tampa, Florida, United States, 33613
Contact: Cynthia Paysor, LPN    813-615-7200 ext 50175    cynthia.paysor@ahss.org   
Contact: Elizabeth Szymanski       eszymanski@mail.uch.org   
Principal Investigator: Scott Bronleewe, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Katie Carssow, RN    404-686-3357    katherine.lee.carssow@emory.edu   
Principal Investigator: Michael Halkos, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Evanston, Illinois, United States, 60208
Contact: Carmen Diaz    312-926-4801    cdiaz@nmh.org   
Contact: Anna Huskin, RN    3126954067    ahuskin@nmh.org   
Principal Investigator: Patrick McCarthy, MD         
SIU- Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62794
Contact: Theresa Boley, RN    217-545-5000    tboley@siumed.edu   
Contact: Cathy Leslie, RN    2175458184    cleslie@siumed.edu   
Principal Investigator: Stephen Hazelrigg, MD         
United States, Indiana
St. Francis Heart Hospital Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Molly Miller    317-893-1948    molly.miller@franciscanalliance.org   
Contact: Amanda Shepler    3178931916    amanda.shepler@franciscanalliance.org   
Principal Investigator: Marc Gerdisch, MD         
Inidiana Heart Center Completed
Indianapolis, Indiana, United States, 46290
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Betsy Osborne    207-662-1489    osborb2@mmc.org   
Contact: Crystal Herron    5187799987    herroc@mmc.org   
Principal Investigator: Scott Buchanan, MD         
United States, Massachusetts
Veteran Affairs Boston Healthcare System Recruiting
West Roxbury, Massachusetts, United States, 02132
Contact: Jennifer M Gabany, CRNP, CCRC    742-822-5613    Jennifer.Gabany@va.gov   
Principal Investigator: Marco Zenati, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cathie Bloem, RN    734-615-6170      
Principal Investigator: Steven Bolling, MD         
Spectrum Health Completed
Grand Rapids, Michigan, United States, 49506
Sparrow Clinical Research Institute Recruiting
Lansing, Michigan, United States, 48910
Contact: Jennifer Boak, RN    517-483-8428    jboak@tciheart.com   
Contact: Nancy Miller, RN    5174838417    nmiller@tciheart.com   
Principal Investigator: Divyakant Gandhi, MD         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Diane Tapp, RN    248-551-0194    diane.tapp@beaumont.edu   
Principal Investigator: Frank Shannon, MD         
Munson Medical Center Active, not recruiting
Traverse City, Michigan, United States, 49684
United States, Minnesota
United Heart & Vascular/Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55102
Contact: Kari Thomas    651-241-2817    kari.thomas@allina.com   
Principal Investigator: John Grehan, MD         
United States, Missouri
Missouri Baptist Medical Center Recruiting
St. Louis, Missouri, United States, 63131
Contact: Cathy Castner    314-996-5287    cfc1237@bjc.org   
Principal Investigator: Michael Mauney, MD         
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Laurie Sinn, RN    314-747-1930    sinnl@wustl.edu   
Contact: Jennifer Bell, RN    314-747-4406    bellj@wustl.edu   
Principal Investigator: Hersch Maniar, MD         
United States, Nebraska
Nebraska Heart Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Deb Baehr    402-328-3939    dbaehr@neheart.com   
Contact: Corey Godfrey    4023283930    cgodfrey@neheart.com   
Principal Investigator: James Wudel, MD         
United States, New Jersey
St. Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Lindsey Meade    973-754-2416    meadel@sjhmc.org   
Principal Investigator: Kourosh Asgarian, MD         
United States, North Carolina
Mission Hospital/Asheville Heart Recruiting
Asheville, North Carolina, United States, 28803
Contact: Leslie E Shell, BSN,RN,CCRC    828-213-5665    Leslie.Shell@msj.orj   
Contact: Susan E Sutherland, PhD    828-213-7038    Susan.Sutherland@msj.org   
Principal Investigator: Mark A Groh, MD         
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Gale Schwarz, RN,CCRC    704-355-4797    Gale.Schwarz@carolinahealthcare.org   
Principal Investigator: Charles Bridges, MD         
Triad Cardiac and Thoracic Surgeons/Cone Health Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Sally Milks, RN    336-832-8069    sally.milks@conehealth.com   
Principal Investigator: Clarence Owen, MD         
United States, North Dakota
Altru Health System Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Brenda Westacott, CCRC    701-780-1845    bwestacott@altru.com   
Principal Investigator: Barry Bjorgaard, MD         
United States, Ohio
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Carol Krabbe    513-862-2877    carol.krabbe@trihealth.com   
Contact: Ginger LaMar, RN    5132533535      
Principal Investigator: J. Michael Smith, MD         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Nadine Norton    216-844-2636    nadine.norton@uhhospitals.org   
Contact: Stacey Mazzurco    2168443130    stacey.mazzurco@uhhospitals.org   
Principal Investigator: Alan Markowitz, MD         
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Tamithy Huber, RN    419-291-5757    tamithy.huber@promedica.org   
Principal Investigator: Michael Moront, MD         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contact: Julia Myers, RN    405-628-6288    jmyers@okheart.com   
Contact: Katrina Eastwood, RN    4056081290    keastwood@okheart.com   
Principal Investigator: Goya Raikar, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Claudia Stone    503-494-4192    stonecl@ohsu.edu   
Principal Investigator: Matthew Slater, MD         
United States, Pennsylvania
Pinnacle Health Hospitals Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Debbie Cassatt, RN    717-231-8632    dcassatt@pinnaclehealth.org   
Contact: Stephanie McMullen, RN    7172318819    smcmullen@pinnaclehealth.org   
Principal Investigator: Mubashir Mumtaz, MD         
Hospital of the University of Pennsylvania (HUP) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rohan Menon    412-609-6325    Rohan.Menon@uphs.upenn.edu   
Contact: Lisa Walsh    215-662-4289    Lisa.Walsh@uphs.upenn.edu   
Principal Investigator: Nimesh Desai, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Ruth Cavales    412-359-6908    rcavales@wpahs.org   
Principal Investigator: Robert Moraca, MD         
United States, Tennessee
Baptist Memorial Hospital Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amber Kirby    901-747-1268    amber@cvsclinic.com   
Contact: Charlotte Porter    901-747-1602    porter@cvsclinic.com   
Principal Investigator: Ed Garrett, MD         
United States, Texas
UT Southwestern University Hospital Recruiting
Dallas, Texas, United States, 75390
Contact: Kristy Piepenbrok       kristy.piepenbrok@utsouthwestern.edu   
Contact: Mary Weyant, RN    2146457700    mary.weyant@utsouthwestern.edu   
Principal Investigator: Michael Jessen, MD         
United States, Utah
St. Mark's Hospital Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Steve Morley, BS, EMT    801-261-2000 ext 329    smorley@jeanbrownresearch.com   
Principal Investigator: Gilbert Schorlemmer, MD         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Linette Klevan, RN    757-388-2425    lrklevan@sentara.com   
Contact: Marci Holladay       mjmedeir@sentara.com   
Principal Investigator: Jonathan Philpott, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Stella Hamman    804-628-1046      
Principal Investigator: Vigneshwar Kasirajan, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Jennifer Nagel, BS    206-386-6462    jennifer.nagel@swedish.org   
Contact: Colleen Truva    2062153982    colleen.truva@swedish.org   
Principal Investigator: Glenn R Barnhart, MD         
United States, Wisconsin
Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Stacey Trawicki, BS    715-847-2273    stacey.trawicki@aspirus.org   
Contact: Jeff Kaliebe    7158472273    jeffk@carefoundation.org   
Principal Investigator: John Johnkoski, MD         
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: March 24, 2014
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 October 22, 2014