nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation



Status:Terminated
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:April 1, 2013
End Date:November 26, 2017

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reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with
THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory
symptomatic paroxysmal atrial fibrillation (PAF).


Inclusion Criteria:

1. Patients with symptomatic paroxysmal AF who have had at least one AF episode
documented within one (1) year prior to enrollment. Documentation may include ECG,
transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or
atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel
blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.

3. Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.

4. Age 18 years or older.

5. Signed Patient Informed Consent Form (ICF).

6. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements.

Exclusion Criteria:

1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
cause.

2. Previous ablation for atrial fibrillation.

3. Patients on amiodarone at any time during the past 3 months prior to enrollment.

4. AF episodes lasting > 7 days.

5. Any cardiac surgery within the past 60 days (2 months).

6. Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve
repair or replacement and presence of a prosthetic valve).

7. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).

8. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12
months).

9. Documented left atrial thrombus on imaging.

10. History of a documented thromboembolic event within the past one (1) year.

11. Diagnosed atrial myxoma.

12. Presence of implanted cardioverter defibrillator (ICD).

13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or
chronic obstructive pulmonary disease) or any other disease or malfunction of the
lungs or respiratory system that produces chronic symptoms.

14. Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this study.

15. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing
age and potential) or breast feeding.

16. Acute illness or active systemic infection or sepsis.

17. Unstable angina.

18. Myocardial infarction within the previous 60 days (2 months).

19. Left ventricular ejection fraction <40%.

20. History of blood clotting or bleeding abnormalities.

21. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists
such as warfarin).

22. Life expectancy less than 365 days (12 months).

23. Enrollment in an investigational study evaluating another device or drug.

24. Uncontrolled heart failure or NYHA Class III or IV heart failure.

25. Presence of intramural thrombus, tumor or other abnormality that precludes catheter
introduction or manipulation.

26. Presence of a condition that precludes vascular access.

27. Left atrial size >50 mm.
We found this trial at
39
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1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Kenneth Ellenbogen, MD
Phone: 804-828-4700
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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1 Shircliff Way
Jacksonville, Florida 32204
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Aman Chugh, MD
Phone: 734-615-2680
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30309
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Austin, Texas 78705
Principal Investigator: Rodney Horton, MD
Phone: 512-458-9410
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Birmingham, Alabama 35294
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbus, Ohio 43210
Principal Investigator: Emile Daoud, MD
Phone: 614-685-4621
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Houston, Texas 77030
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Imeldalaan, Bonheiden 2820
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Kansas City, Kansas 66160
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Principal Investigator: Gery Tomassoni, MD
Phone: 859-260-6440
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Los Angeles, California 90017
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Morristown, New Jersey 07962
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
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Nashville, Tennessee 37203
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301 Memorial Medical Parkway
New Smyrna Beach, Florida 32169
Principal Investigator: Huijian Wang, MD
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70 Washington Square S
New York, New York 10012
(212) 998-1212
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New York, New York 10029
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Newport Beach, California 92658
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Principal Investigator: William H Spear, MD
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oklahoma City, Oklahoma 73120
Principal Investigator: Mark Harvey, MD
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Palo Alto, California 94303
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Philadelphia, Pennsylvania 19141
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 53226
Principal Investigator: Vijay Swarup, MD
Phone: 602-456-2342
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Plano, Texas 75093
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Redwood City, California 94062
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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805 Cooper Road
Voorhees, New Jersey 08043
Principal Investigator: Darius P Sholevar, MD
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