DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being
performed at multiple centers in the United States, Canada and Europe. The study will
evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients
with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with
either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation
Catheter manufactured by Abbott. Patients will be followed for 12 months.

Key Inclusion Criteria:

- Above 18 years of age

- Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have
had ≥ 2 episodes of PAF reported within the 12 months prior to index ablation
procedure

- At least one episode of PAF documented by electrocardiographic data within 12 months
prior to index ablation procedure and a physician's note indicating recurrent
self-terminating AF

- Failure or intolerance of at least one Class I-IV anti-arrhythmic AAD for treatment of
PAF

Exclusion Criteria:

- LA diameter > 5.5 cm

- Left ventricular ejection fraction < 35%

- Currently NYHA Class III or IV or exhibits uncontrolled heart failure

- Myocardial infarction, unstable angina, cardiac surgery or coronary intervention
within 3 months of the ablation procedure

- Documented stroke, CVA, TIA or suspected neurological event within 6 months of the
ablation procedure