Clinical trial NCT01824394: nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Official title: reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: nMARQ
Atrial Fibrillation
Drug Refractory
Radio Frequency
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Early Onset Primary Adverse Events
timeFrame: 30 days post-procedure
measure: Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
timeFrame: 30 days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: