REVOLUTION (WFCC-133) - Treatment of Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: nMARQ™ System
Intervention description: The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of the Circular and
      Crescent Mapping and Ablation catheters and the workflow of the Multi-Electrode Irrigated
      Pulmonary Vein Isolation System when used for the treatment of drug refractory symptomatic
      paroxysmal atrial fibrillation (PAF).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with symptomatic Paroxysmal Atrial Fibrillation (PAF) who have had at least
             one documented Atrial Fibrillation (AF) episode in the twelve (12) months prior to
             enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor
             (TTM), Holter Monitor (HM), or telemetry strip.

          2. Failure of at least one antiarrhythmic drug for AF (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 intolerable side effects.

          3. Age 18 years or older.

          4. Able and willing to comply with all pre-, post- and follow-up testing and
             requirements.

          5. Signed Patient Informed Consent Form.

        Exclusion Criteria:

          1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
             cause.

          2. Patients with Persistent or Long-standing AF (AF episode lasting > 30 days in
             duration.

          3. Diagnosed atrial myxoma.

          4. Left atrial size > 5.5cm.

          5. Left Ventricular ejection fraction < 40%.

          6. Contraindication to Computed Axial Tomography/Magnetic Resonance Imaging (CT/MRI)
             procedures

          7. New York Heart Association Class III or IV.

          8. Previous ablation for enrolled arrhythmia (AF).

          9. Documented left atrial thrombus on imaging (example: transesophageal echocardiography
             or intracardiac echocardiography).

         10. Myocardial Infarction within the previous 60 days (2 months).

         11. Any valvular cardiac surgical procedure (that is, valve repair or replacement and
             presence of a prosthetic valve).

         12. Coronary artery bypass graft procedure with the last 180 days 6 months.

         13. Cardiac Surgery (that is, ventriculotomy, atriotomy) within the past 60 days (2
             months).

         14. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12
             months).

         15. History of documented thromboembolic event within the past one (1) year.

         16. Significant pulmonary disease, (example: restrictive pulmonary disease, constrictive
             or chronic obstructive pulmonary disease) or any other disease or malfunctions of the
             lungs or respiratory system that produces chronic symptoms.

         17. Significant congenital anomaly or medical problem that in the opinion of the
             investigator would preclude enrollment in this study.

         18. Active illness or active systemic infection or sepsis.

         19. Unstable angina.

         20. History of blood clotting or bleeding abnormalities.

         21. Contraindication to anticoagulation (that is, Heparin or Warfarin).

         22. Life expectancy less than 365 days (12 months)

         23. Presence of intramural thrombus, tumor or other abnormality that precludes catheter
             introduction or manipulation.

         24. Women who are pregnant (as evidence by pregnancy test if subject is of child bearing
             potential) and/or breast feeding.

         25. Presence of a condition that precludes vascular access.

         26. Enrollment in an investigational study evaluating another device or drug.