TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute
safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a
performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35
investigational sites in the US, Europe, and Australia. Only sites that enroll at least one
subject will be part of the analysis population. No center may contribute more than 20% of
the total number of enrollments without sponsor pre-approval to exceed this proportion and at
least 50% of subjects must be from the United States.

Inclusion Criteria:

- Plans to undergo a catheter ablation procedure due to symptomatic PAF that is
refractory or intolerant to at least one Class I or III antiarrhythmic drug

- Physician's note indicating recurrent self-terminating AF

- One electrocardiographically documented AF episode within 6 months prior to the index
ablation procedure

- At least 18 years of age

- Able and willing to comply with all trial requirements

- Informed of the nature of the trial, agreed to its provisions and has provided written
informed consent as approved by the Institutional Review Board/Ethics Committee
(IRB/EC) of the respective clinical trial site.

Exclusion Criteria:

- Persistent or long-standing persistent atrial fibrillation (AF)

- Four or more cardioversions in the past 12 months

- Active systemic infection

- Known presence of cardiac thrombus

- Implanted with implantable cardiac defibrillator (ICD)

- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol
intoxication, and other major surgical procedures in the preceding 3 months

- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3
months

- Left atrial diameter > 5.0 cm

- Left ventricular ejection fraction < 35%

- New York Heart Association (NYHA) class III or IV

- Previous left atrial surgical or catheter ablation procedure

- Left atrial surgical procedure or incision with resulting scar

- Previous tricuspid or mitral valve replacement or repair

- Heart disease in which corrective surgery is anticipated within 6 months

- Bleeding diathesis or suspected procoagulant state

- Contraindication to long term antithromboembolic therapy

- Presence of any condition that precludes appropriate vascular access

- Renal failure requiring dialysis

- Known sensitivity to contrast media (if needed during the procedure) that cannot be
controlled with pre-medication

- Severe 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 severe chronic symptoms

- Pregnant or nursing

- Presence of other anatomic or comorbid conditions that, in the investigator's opinion,
could limit the patient's ability to participate in the clinical trial or to comply
with follow up requirements, or impact the scientific soundness of the clinical trial
results

- Patient is currently participating in another clinical trial or has participated in a
clinical trial within 30 days prior to screening that may interfere with this clinical
trial

- Patient is unlikely to survive the protocol follow up period of 12 months

- Body mass index > 40 kg/m2

- Vulnerable subject