ABLATE AF Registry Trial



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:June 2010
End Date:June 2012
Contact:Rebecca Walters
Phone:1-800-401-3506

Use our guide to learn which trials are right for you!

ABLATE AF Registry Trial (AtriCure Synergy Bipolar RF Energy Lesions for Non-paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery)


ABLATE AF is a prospective, non-randomized multi-center clinical trial to demonstrate the
safety and effectiveness of the AtriCure Bipolar System for treating non-paroxysmal forms of
atrial fibrillation.


Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age

2. Subject has history of a non-paroxysmal form of AF

3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for
one or more of the following:

- Mitral valve repair or replacement

- Aortic valve repair or replacement

- Tricuspid valve repair or replacement

- Coronary Artery Bypass procedures

4. Subject's Left Ventricular Ejection Fraction ≥ 30%

5. Subject is able and willing to provide written informed consent and comply with study
requirements

6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

1. Stand alone AF without indication(s) for concomitant CABG, valve surgery

2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical
Maze procedure

3. Wolff-Parkinson-White syndrome

4. Prior cardiac surgery (Redo)

5. Class IV NYHA heart failure symptoms

6. Prior history of cerebrovascular accidents within 6 months or at any time if there is
residual neurological deficit

7. Documented MI within 6 weeks prior to study enrollment

8. Need for emergent cardiac surgery (i.e. cardiogenic shock)

9. Known carotid artery stenosis greater than 80%

10. LA size greater than or equal to 8cm

11. Current diagnosis of active systemic infection

12. Severe peripheral arterial occlusive disease defined as claudication with minimal
exertion

13. Pregnancy or desire to get pregnant within 12-months of the study enrollment

14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

15. Renal failure requiring dialysis or hepatic failure

16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

17. Therapy resulting in compromised tissue integrity including: thoracic radiation,
chemotherapy, long term treatment with oral or injected steroids, or known
connective tissue disorders
We found this trial at
18
sites
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Indianapolis, Indiana 46237
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Lincoln, Nebraska 68526
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
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...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
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...
?
mi
from
Traverse City, MI
Click here to add this to my saved trials
Wausau, Wisconsin 54401
?
mi
from
Wausau, WI
Click here to add this to my saved trials
Wormleysburg, Pennsylvania 17043
?
mi
from
Wormleysburg, PA
Click here to add this to my saved trials