Clinical trial NCT01656772: Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Official title: Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: magnetic navigation
robotic control
RMT ThermoCool catheter
Lead sponsor: Stereotaxis
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.
timeFrame: Peri-procedural
measure: Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.
timeFrame: 7 days Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Antwerpen
country: Belgium
facility: ZNA Campus Middelheim Lindendreef 1
city: Bad Oeynhausen
country: Germany
facility: IKFE HDZ GbmH
Study officials:
affiliation: Stereotaxis Inc
name: Qun Sha, MD
role: STUDY_DIRECTOR
References: