Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF)

A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between
those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary
vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.

Inclusion Criteria:

- Reported incidence of at least two (2) documented episodes of symptomatic paroxysmal
atrial fibrillation (AF) during the six months preceding trial entry (at least one
episode should be documented by rhythm strip or ECG).

- Attempt of at least one Class I or III anti-arrhythmia drug with failure defined as
recurrence of symptomatic AF or adverse drug effect resulting in stopping the
medication (drug duration and dose will be documented).

- Left atrial size <55mm in largest dimension (typically atrial septum to carina of
left pulmonary veins) as measured and image documented by preoperative imaging (CT or
MRI)

- Anticoagulation therapy-Oral anticoagulation required (in the case of Warfarin,
therapeutic International Normalized Ratio (INR) for at least three weeks prior to
randomization) for those subjects who meet two or more of the following criteria:

1. Age 65 years or older

2. Diabetes

3. Prior stroke or transient ischemic attack

4. Congestive heart failure

5. Hypertension with systolic>165 mm Hg

- Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the
procedure)

- Sustained AF-if the patient is not experiencing spontaneous, sustained AF (>10 min
uninterrupted), sustained AF may be induced by burst atrial pacing with or without
isoproterenol infusion in conventional clinical fashion.

Exclusion Criteria:

- Previous catheter or surgical left atrial ablation

- Structural heart disease of clinical significance including

- Congenital heart disease where either the underlying abnormality or its correction
prohibits or increases the risk of ablation

- Myocardial infarction (MI) within the past three (3) months

- Any concomitant arrhythmia or therapy that could interfere with the interpretation of
the results from this study

- Atrial Septal Defect closure device; Left Atrial Appendage closure device; prosthetic
mitral or tricuspid valve

- Anaphylactic allergy to contrast media

- Atrial fibrillation secondary to electrolyte imbalance

1. thyroid disease

2. reversible non-cardiac cause

- Poor general health that, in the opinion of the investigator, will not allow the
patient to be a good study candidate (i.e. other disease processes, mental capacity,
etc.)

- Reversible cause of atrial fibrillation (e.g. surgery, hyperthyroidism, pericarditis)

- Contraindication to heparin and warfarin/other new oral anticoagulants (e.g.
dabigatran, rivaroxaban, apixaban [when available])

- History of pulmonary embolus within one year of enrollment

- Acute pulmonary edema

- Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE)
performed within 72 hours of the procedure if deemed appropriate by the investigator

- Any history of a cerebrovascular disease-including stroke or Transient Ischemic
Attack

- Any anticipation of cardiac transplantation or other cardiac surgery within the next
365 days (12 months)

- History of documented thromboembolic event within the past one year

- Diagnosed atrial myxoma

- Significant pulmonary disease

- Acute illness or active systemic infection or sepsis

- Any history of blood clotting abnormalities or bleeding tendencies unrelated to
supratherapeutic anticoagulation

- Life expectancy <365 days (12 months)

- Any intracardiac thrombus, tumor. or other abnormality that precludes safe catheter
introduction or manipulation

- Continuous AF episode lasting >7 days immediately prior to the procedure without any
sinus rhythm

- Patients who have previously undergone cardioversion are excluded from participation
in the study unless there is documentation that cardioversion has been performed
within 72 hours of episode onset

- Amiodarone use in the last 6 months