Back to resultsVdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study (VERSATILE)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vdrive Lasso navigation
Manual Lasso navigation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring magnetic navigation, robotic control, RMT ThermoCool catheter
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
Sites / Locations
- Central Baptist Hospital
- Texas Cardiac Arrhythmia Institute
- Baylor Research Institute
- ZNA Campus Middelheim Lindendreef 1
- IKFE HDZ GbmH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual Lasso navigation
Vdrive Lasso navigation
Arm Description
Use of conventional manual navigation techniques with the Lasso catheter
Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Outcomes
Primary Outcome Measures
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 α = 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.
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 α = 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01656772
Brief Title
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Acronym
VERSATILE
Official Title
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stereotaxis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
magnetic navigation, robotic control, RMT ThermoCool catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Lasso navigation
Arm Type
Active Comparator
Arm Description
Use of conventional manual navigation techniques with the Lasso catheter
Arm Title
Vdrive Lasso navigation
Arm Type
Experimental
Arm Description
Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Intervention Type
Device
Intervention Name(s)
Vdrive Lasso navigation
Intervention Description
Remote robotic Lasso navigation
Intervention Type
Procedure
Intervention Name(s)
Manual Lasso navigation
Intervention Description
Manually maneuver a Lasso catheter
Primary Outcome Measure Information:
Title
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.
Description
Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 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.
Time Frame
Peri-procedural
Title
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.
Description
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 α = 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.
Time Frame
7 days Follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qun Sha, MD
Organizational Affiliation
Stereotaxis Inc
Official's Role
Study Director
Facility Information:
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
ZNA Campus Middelheim Lindendreef 1
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
IKFE HDZ GbmH
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
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