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

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

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
sites
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1 Shircliff Way
Jacksonville, Florida 32204
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
Principal Investigator: Rodney Horton, MD
Phone: 512-458-9410
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham, Alabama 35294
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: Emile Daoud, MD
Phone: 614-685-4621
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Abdi Rasekh, MD
Phone: 832-355-3494
?
mi
from
Houston, TX
Click here to add this to my saved trials
Imeldalaan, Bonheiden 2820
?
mi
from
Imeldalaan,
Click here to add this to my saved trials
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...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Morristown, New Jersey 07962
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
?
mi
from
Murray, UT
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
301 Memorial Medical Parkway
New Smyrna Beach, Florida 32169
Principal Investigator: Huijian Wang, MD
?
mi
from
New Smyrna Beach, FL
Click here to add this to my saved trials
70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10029
Principal Investigator: Vivek Reddy, MD
Phone: 212-824-8927
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport Beach, California 92658
Principal Investigator: Rajesh Banker, MD
Phone: 949-764-4509
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
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
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
Principal Investigator: Mark Harvey, MD
Phone: 405-608-1284
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Palo Alto, California 94303
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19141
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 53226
Principal Investigator: Vijay Swarup, MD
Phone: 602-456-2342
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: J. Brian DeVille, MD
Phone: 469-814-4185
?
mi
from
Plano, TX
Click here to add this to my saved trials
Redwood City, California 94062
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
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...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
?
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Darryl Wells, MD
Phone: 206-320-3917
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
805 Cooper Road
Voorhees, New Jersey 08043
Principal Investigator: Darius P Sholevar, MD
Phone: 856-673-1346
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials