At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 120 enrolled
Drug / intervention
Vdrive Lasso navigation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
In Brief
A Phase 3 clinical trial evaluating Vdrive Lasso navigation and Manual Lasso navigation for Atrial Fibrillation. Completed, enrolled 120 participants across 5 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBelgium, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedAug 3, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago
Interventions
Vdrive Lasso navigationdevice
Remote robotic Lasso navigation
Manual Lasso navigationprocedure
Manually maneuver a Lasso catheter