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

Stereotaxis

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: Vdrive Lasso navigation; Procedure: Manual Lasso navigation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656772

CLIN-020

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Manual Lasso navigation

Active Comparator group

Description:

Use of conventional manual navigation techniques with the Lasso catheter

Treatment:

Procedure: Manual Lasso navigation

Vdrive Lasso navigation

Experimental group

Description:

Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter

Treatment:

Device: Vdrive Lasso navigation