Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vdrive Lasso navigation, Manual Lasso navigation · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| Manual Lasso navigation | ACTIVE_COMPARATOR | Use of conventional manual navigation techniques with the Lasso catheter |
| Vdrive Lasso navigation | EXPERIMENTAL | Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter |
| Name | Type | Description |
|---|---|---|
| Vdrive Lasso navigation | DEVICE | Remote robotic Lasso navigation |
| Manual Lasso navigation | PROCEDURE | Manually maneuver a Lasso catheter |
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: *...
Vdrive Lasso navigation is a remote steering system used during electrophysiology procedures for atrial fibrillation. It is designed to help physicians navigate a Lasso catheter within the heart. The system is being evaluated in a clinical trial for its safety and effectiveness in these procedures.
Vdrive Lasso navigation targets the heart's electrical system, specifically aiding in the navigation of a Lasso mapping catheter during electrophysiology procedures for atrial fibrillation. The system is intended to improve catheter control and stability during mapping of the heart's electrical activity.
Vdrive Lasso navigation is developed by Stereotaxis, Inc., a company traded on the NYSE American under the ticker symbol STXS. Stereotaxis specializes in robotic navigation systems for cardiovascular procedures.
Vdrive Lasso navigation is in Phase 3 clinical development. It is an investigational device and has not been approved by the FDA. A Phase 3 clinical trial has been completed to evaluate its use in atrial fibrillation procedures.
Vdrive Lasso navigation has one completed Phase 3 clinical trial, NCT01656772, titled 'Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study.' The trial enrolled 120 participants with atrial fibrillation across the United States, Belgium, and Germany.
Vdrive Lasso navigation and Manual Lasso navigation are both names associated with the same system developed by Stereotaxis. The system can be used in either a remote (Vdrive) or manual mode for navigating the Lasso catheter during electrophysiology procedures.