Atrial Fibrillation Clinical Trial
Official title:
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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