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

Atrial Fibrillation Clinical Trial

— VERSATILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656772
• Other study ID #: CLIN-020
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: June 4, 2015
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2015
• Source: Stereotaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Vdrive Lasso navigation
Remote robotic Lasso navigation

Procedure:
• Manual Lasso navigation
Manually maneuver a Lasso catheter

Locations

Country	Name	City	State
Belgium	ZNA Campus Middelheim Lindendreef 1	Antwerpen
Germany	IKFE HDZ GbmH	Bad Oeynhausen
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas
United States	Baylor Research Institute	Dallas	Texas
United States	Central Baptist Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Stereotaxis

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the a = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.	Peri-procedural	No
Primary	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.	The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the a = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.	7 days Follow-up	Yes