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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:September 2012
End Date:March 21, 2018

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AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

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.

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.

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.
We found this trial at
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Lansing, Michigan 48912
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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860 South Columbia Road
Grand Forks, North Dakota 58201
701-780-1750
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Asheville, North Carolina 28803
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Cincinnati, Ohio 45220
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Dallas, TX
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Evanston, Illinois 60208
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Fort Myers, Florida 33901
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Grand Rapids, Michigan 49503
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Greensboro, North Carolina 27401
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Harrisburg, Pennsylvania 17104
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80 Seymour St
Hartford, Connecticut 6102
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Indianapolis, Indiana 46290
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Indianapolis, Indiana 46237
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Lincoln, Nebraska 68526
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Los Angeles, California 90095
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Los Angeles, California 90033
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Memphis, Tennessee 38120
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Minneapolis, MN
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oklahoma City, Oklahoma 73120
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Paterson, New Jersey 07503
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Philadelphia, Pennsylvania 19104
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63110
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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701 6th Street South
Saint Petersburg, Florida 33701
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Saint Petersburg, Florida 33709
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Salt Lake City, Utah 84124
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Scottsdale, AZ
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Springfield, Illinois 62794
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Tampa, Florida 33613
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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Wausau, Wisconsin 54401
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West Hollywood, California 90048
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West Roxbury, Massachusetts 02132
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