Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study

Key to the success of an electrophysiology procedure is the ability to accurately map, sense
and pace the heart. Electrophysiology mapping catheters are available in a variety of
shapes and electrode configurations. The majority of these catheters are manipulated
manually by the physician. The Vdrive simplifies these manipulations by allowing an
operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping
catheter. The circular mapping catheter is not altered in structure, function or indication
in the same manner as the predicate device (Cardiodrive Catheter Advancement System).

This is a prospective, randomized, non-blinded, controlled study comparing manual navigation
of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120
patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40
patients in the manual navigation arm. Patients will be enrolled at a minimum of one site
in the European Union where the product is currently marketed and the United States, where
the Vdrive is considered to be investigational.

Inclusion Criteria:

- Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter

- Subject must be at least 18 years of age

- Subject must be male, female of no childbearing potential, or a female that has a
negative pregnancy test prior to randomization

Exclusion Criteria:

- Unable to safely expose subject to a magnetic field

- Prior AF ablation procedure

- Patients with fewer than 4 PVs are excluded

- Patients with persistent AF in whom early recurrence of AF following cardioversion
would preclude completion of the pacing maneuvers described in the protocol or
patients with other conditions that would similarly preclude completion of the pacing
maneuvers

- Contraindication to procedure or unable to return for follow-up

- History of clotting disorder, bleeding abnormalities or contraindication to
anticoagulation

- Actively participating in other cardiac device trial(s)

- Currently pregnant

- Under 18 years of age

- Prosthetic valves

- Atrial abnormalities (thrombus, myxoma or baffle)

- Other exclusions per the investigator