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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual Lasso navigation

Use of conventional manual navigation techniques with the Lasso catheter

Group Type ACTIVE_COMPARATOR

Manual Lasso navigation

Intervention Type PROCEDURE

Manually maneuver a Lasso catheter

Vdrive Lasso navigation

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

Group Type EXPERIMENTAL

Vdrive Lasso navigation

Intervention Type DEVICE

Remote robotic Lasso navigation

Interventions

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Vdrive Lasso navigation

Remote robotic Lasso navigation

Intervention Type DEVICE

Manual Lasso navigation

Manually maneuver a Lasso catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No