Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
VERSATILE
1 other identifier
interventional
120
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Aug 2012
Shorter than P25 for phase_3 atrial-fibrillation
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2015
CompletedJuly 1, 2015
June 1, 2015
1.3 years
July 30, 2012
May 20, 2015
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Peri-procedural
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.
7 days Follow-up
Study Arms (2)
Manual Lasso navigation
ACTIVE COMPARATORUse of conventional manual navigation techniques with the Lasso catheter
Vdrive Lasso navigation
EXPERIMENTALUse of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stereotaxislead
Study Sites (5)
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78705, United States
Baylor Research Institute
Dallas, Texas, 75204, United States
ZNA Campus Middelheim Lindendreef 1
Antwerp, Antwerpen, 2020, Belgium
IKFE HDZ GbmH
Bad Oeynhausen, Bad Oeynhausen, 32545, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Qun Sha M.D. (Study Director)
- Organization
- Stereotaxis, Inc.
Study Officials
- STUDY DIRECTOR
Qun Sha, MD
Stereotaxis Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2012
First Posted
August 3, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 1, 2015
Results First Posted
June 4, 2015
Record last verified: 2015-06