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
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5801 South Ellis Avenue
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330 Brookline Ave
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1 Shircliff Way
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1211 Medical Center Dr
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1500 E Medical Center Dr
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Birmingham, Alabama 35294
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171 Ashley Avenue
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2049 E 100th St
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Columbus, Ohio 43210
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2301 Erwin Rd
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Houston, Texas 77030
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Imeldalaan, Bonheiden 2820
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1740 Nicholasville Rd
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800 E 28th St
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Morristown, New Jersey 07962
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5121 S Cottonwood St
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301 Memorial Medical Parkway
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70 Washington Square S
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Oklahoma City, Oklahoma 73120
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601 E Rollins St
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1250 E. Marshall St.
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