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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Fort Myers, Florida 33901
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1720 2nd Ave S
Birmingham, Alabama 35233
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1000 Blythe Blvd
Charlotte, North Carolina 28203
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860 South Columbia Road
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22 Bramhall St
Portland, Maine 04102
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3181 Southwest Sam Jackson Park Road
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500 S State St
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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
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Evanston, Illinois 60208
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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
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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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Memphis, Tennessee 38120
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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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
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Richmond, Virginia 23298
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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
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701 6th Street South
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Salt Lake City, Utah 84124
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7901 Frost Street
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5300 Tallman Ave NW
Seattle, Washington 98122
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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
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105 Sixth St
Traverse City, Michigan 49684
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Wausau, Wisconsin 54401
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