Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation

Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to
demonstrate the safety and effectiveness when compared to an historical control performance
goal.

The trial will enroll 185 subjects who are candidates for catheter ablation.

Key Inclusion Criteria:

- Symptomatic paroxysmal AF with one electrocardiographically documented AF episode
within 6 months prior to enrollment and a a physician's note indicating recurrent
self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG);
Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.

- Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent
symptomatic AF, contraindicated, or intolerable to the AAD.

- Age 18 years or older.

Key Exclusion Criteria:

- Previous surgical or catheter ablation for atrial fibrillation.

- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
cause.

- Previously diagnosed with persistent or long-standing persistent AF and/or Continuous
AF > 7 days.

- Valve repair or replacement or presence of a prosthetic valve.

- CABG surgery within the past 6 months (180 days).

- Any carotid stenting or endarterectomy within the past 6 months.

- Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical
procedure within the past 6 months.

- Documented left atrium (LA) thrombus within 1 day prior to the index procedure.

- Documented LA size > 50 mm.

- Documented LVEF < 40%.

- Contraindication to anticoagulation (e.g., heparin).

- MI/PCI within the past 2 months.

- Documented thromboembolic event (including transient ischemic attack) within the past
12 months.

- Uncontrolled heart failure or New York Heart Association (NYHA) function class III or
IV.

- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.

- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).

- Women who are pregnant, lactating, or who are of child bearing age and plan on
becoming pregnant during the course of the clinical investigation.