nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: nMARQ Navigation Catheters; NaviStar ThermoCool Catheters
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 481.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nMARQ; Atrial Fibrillation; Drug Refractory; Radio Frequency

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.